Clinical Trials

Clinical Trial To Evaluate The The ReliantHeart HeartAssist 5® VAD System In Patients Awaiting Heart Transplantation

Rochester, MN

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Clinical Trial To Evaluate The The ReliantHeart HeartAssist 5® VAD System In Patients Awaiting Heart Transplantation

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

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Site IRB:
14-008438
NCT ID:
NCT02205411
Sponsor Protocol Number:
CAP00030

Treatment For CI-DME In Eyes With Very Good VA Study

Rochester, MN

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Treatment For CI-DME In Eyes With Very Good VA Study

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens.

The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF.

Secondary objectives include:

Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity
For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment
Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT central subfield (CSF) thickness, adjusted for baseline mean thickness
Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between treatment groups
Comparing safety outcomes between treatment groups
Comparing associated treatment and follow-up exam costs between treatment groups

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

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Site IRB:
14-002505
NCT ID:
NCT01909791
Sponsor Protocol Number:
14-002505

Hummingbird TTS Ear Tube Delivery Study

Rochester, MN

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Hummingbird TTS Ear Tube Delivery Study

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

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Site IRB:
13-009142
NCT ID:
NCT02165384
Sponsor Protocol Number:
13-009142

Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer

Rochester, MN

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Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

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Site IRB:
16-000484
NCT ID:
NCT02339558
Sponsor Protocol Number:
MC1471

A Clinical Trial To Evaluate The HeartWare Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)

Rochester, MN

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A Clinical Trial To Evaluate The HeartWare Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 5 years post implant.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

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Site IRB:
13-006972
NCT ID:
NCT01966458
Sponsor Protocol Number:
HW004-A Ver. 3.0

TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

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EdoxabaN or Warfarin Therapy In Cardiovascular Implantable Electrical Device Procedures in Patients With Non-Valvular Atrial Fibrillation

Jacksonville, FL

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EdoxabaN or Warfarin Therapy In Cardiovascular Implantable Electrical Device Procedures in Patients With Non-Valvular Atrial Fibrillation

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
4
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Closed for enrollment	View complete study & contact information

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Site IRB:
16-000379
NCT ID:
NCT02561897
Sponsor Protocol Number:
EPRF2015-01

A Study Relating Voice Characteristics and Cardiovascular Disease / Pulmonary Hypertension

Rochester, MN

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A Study Relating Voice Characteristics and Cardiovascular Disease / Pulmonary Hypertension

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to see if a new voice signal recording software program, can find a connection between abnormal voice signals and the presence and severity of cardiovascula disease / Pulmonary Hypertenison.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
14-000058
Sponsor Protocol Number:
14-000058

A Study Comparing Air versus Blood with Saline as Contrast Shading for Echocardiographic Imaging of the Right Heart and Shunts

Rochester, MN

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A Study Comparing Air versus Blood with Saline as Contrast Shading for Echocardiographic Imaging of the Right Heart and Shunts

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The study aims to answer whether the use of a mixture of blood and saline alone (limited air) provides the same degree of right-heart contrast enhancement as compared to the standard agitated saline (with air), during echocardiograms.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
15-004591
NCT ID:
NCT02661529
Sponsor Protocol Number:
15-004591

A Study Of Ubenimex In Patients With Pulmonary Arterial Hypertension

Rochester, MN

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A Study Of Ubenimex In Patients With Pulmonary Arterial Hypertension

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of ubenimex in patients who have pulmonary arterial hypertension, to improve exercise capacity and delay clinical worsening.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, MN	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
16-009039
NCT ID:
NCT02664558
Sponsor Protocol Number:
EIG-UBX-001

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Search Results 871-880 of 2056 for surgery

Clinical Trial To Evaluate The The ReliantHeart HeartAssist 5® VAD System In Patients Awaiting Heart Transplantation

Treatment For CI-DME In Eyes With Very Good VA Study

Hummingbird TTS Ear Tube Delivery Study

Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer

A Clinical Trial To Evaluate The HeartWare Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)

TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

EdoxabaN or Warfarin Therapy In Cardiovascular Implantable Electrical Device Procedures in Patients With Non-Valvular Atrial Fibrillation

A Study Relating Voice Characteristics and Cardiovascular Disease / Pulmonary Hypertension

A Study Comparing Air versus Blood with Saline as Contrast Shading for Echocardiographic Imaging of the Right Heart and Shunts

A Study Of Ubenimex In Patients With Pulmonary Arterial Hypertension

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