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A Study to Assess Emotional Experiences in Patients with Symptomatic Heart Failure and Left Ventricular Assist Devices
Rochester, MN
The objectives of this study are to use qualitative methods to characterize patients’ distress, to use qualitative methods to explore how distress can impact healthcare behaviors and caregiver support; specifically, their motivation to sustain critical lifestyle changes and provide assertive communication with caregivers and medical teams, and to use qualitative methodology to explore if themes found in patients with symptomatic heart failure (HF) translate to patients with left ventricular assist devices (LVAD) or if they will be superseded by LVAD-specific themes.
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Platelet Function Monitoring for Left Ventricular Assist Device (LVAD) Placement
Rochester, MN
As a part of LVAD studies, platelet function tests are commonly completed. These tests measure the ability of platelets to help blood clot. We would like to gather information to help standardize laboratory tests for management of platelet function after LVAD placement.
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A Study to Establish a Product Surveillance Registry (DTPAS) Apogee (addendum to the Medtronic, Inc. Product Surveillance Registry / Destination Therapy (DT) Post Approval Study (PAS)) Platform Addendum
Jacksonville, FL
The primary purpose of this study is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use.
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AKI Prevention and Early Intervention in Patients Undergoing VAD Placement
Rochester, MN
The investigators are doing this research to find out if more careful assessment and elimination of potential risk factors of acute kidney injury (AKI) during the subject's perioperative period will reduce their chance of kidney damage and kidney damage related problems.
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Clinical Use of the Impella RP System
Rochester, MN
This Is a Humanitarian Use Protocol for the Impella RP® System which is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
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A Study to Assess Respiratory Muscle Training as a Quality Improvement of Perioperative Care in LVAD Patients
Rochester, MN
The objectives of this study are to determine the best method for integration of respiratory muscle training (RMT) into the clinical ventricular assist device (VAD) practice at Mayo, to determine the clinical benefits of using RMT in the VAD population at Mayo Clinic, to gain initial insight on means by which RMT can impact clinical outcomes in the VAD population, and to create an algorithm for integration of perioperative RMT in the VAD and other distinct populations at Mayo Clinic.
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A Study to Compare Microembolic Signal Detection and Cerebral Vasomotor Reactivity on Transcranial Doppler in Patients with Left Ventricular Assistance Devices
Jacksonville, FL
The purpose of this study is to compare microembolic signal detection (MSD) and cerebral vasomotor reactivity (CVR) on transcranial doppler in patients with left ventricular assistance devices.
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A Post-Approval Study of the Pivotal Cohort Extended Follow-Up for MOMENTUM 3
Rochester, MN
The primary purpose of this study is to report the composite endpoint of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 5-years post-implant in subjects who were implanted with the HM3 or HMII LVAS in the MOMENTUM 3 IDE trial and are ongoing at the 2-year follow-up.
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IQ-ECG STUDY - Improve the Quality of ElectroCardioGrams in Ventricular Assist Device Patients
Rochester, MN
The main objective of this study to assess the quality of the ECG readings between different filters from both the GE machine and the Smartheart device.
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A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
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Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device (VAD) Patients
No Locations
The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD) patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test. Also, in patients with gastrointestinal bleeding present, to summarize the extent of gastrointestinal bleeding; to examine the behavior of HemoQuant fecal occult blood test over time by estimating the proportion of VAD patients with a positive test prior to implantation; at one week, one month, three months, six months and one year post implantation, and after explantation of the VAD and to evaluate whether presence of any abnormal fecal HemoQuant test is ...
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A Study to Evaluate the Impact of Pre-Procedural Planning with 3D Printed Cardiac Models for Ventricular Assist Device Placement in Patients with Congenital Heart Disease
Rochester, MN
The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will undergo a ventricular assist device (VAD) placement. The investigators want to study the correlation of having a 3D printed model with improvement in patient outcomes and compare those with patients who have had a VAD placement without a 3D model.
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A Study of New Technology CT Scans for checking Left Ventricular Assist Devices
Rochester, MN
The purpose of this study is to measure the performance of Dual-Energy CT scans that are able to reduce interference caused by metal objects, and then compare with standard echocardiography for checking patients with LVAD devices.
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Virtual World-based Cardiac Rehabilitation Program to Encourage Healthy Lifestyle Choices Among Cardiac Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The aim of this project is to assess the feasibility and utility of a virtual world-based cardiac rehabilitation (CR) program as an extension of a face-to-face conventional CR program (Destination Rehab).