Cara CDRM (Conduction Disturbance Risk Monitor) 2.0
Overview
Tab Title Description
Study type
InterventionalDescribes 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 IDs
Site IRB
- Rochester, Minnesota: 22-003591
NCT ID: NCT05465655
About this study
The purpose of this study is to establish the safety of using Cara™ Monitor used in TAVR, and to estimate the effect of Cara Monitor on reduction of NOCD post TAVR compared to patients treated and followed per regular site-specific practice.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject must be ≥ 18 years of age.
- Subject meets indications for TAVR using approved devices.
- The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Subject is willing to comply with specified follow-up evaluations.
- Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.
Exclusion Criteria:
- Patient with any implanted or have an indication for treatment with rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline.
- Any contraindication to the TAVR procedure according to the instructions for use.
- Subject is less than the legal age of consent, legally incompetent, or otherwise vulnerable.
- Patients who have a planned treatment with any other investigational device, drug or procedure (excluding registries) during the study period.
Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mackram Eleid, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available