DRKS00008923
Active, not recruiting
Phase 4
High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: a Randomized Controlled Trial Comparing MitraClip® to Surgical Therapy - HiRiDe Trial
Klinikdirektor, Klinik für Herz- und Gefäßchirurgie0 sites5 target enrollmentJuly 29, 2015
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Degenerative Mitral Regurgitation
- Sponsor
- Klinikdirektor, Klinik für Herz- und Gefäßchirurgie
- Enrollment
- 5
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Severe (4\+) DMR (degenerative mitral regurgitation), or 3\+ DMR
- •\- NYHA Functional Class III or IV
- •\- Mitral valve anatomy should be suitable for both MitraClip® and Mitral valve surgery (repair or replacement)
- •\- Subjects meet the following conditions:
- •Age \>\=18 and high or intermediate risk with STS calculated mortality (using the repair calculator) \>\=3% and \<\=10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify possible risk factors
- •\- Patient is operable
- •\- Signed by the subject and dated approved informed consent prior to any study related procedure
- •\- Available and able to return to study site for post\-procedural follow\-up examination
Exclusion Criteria
- •\- Patient incapable to approve the informed consent or Emergency Cases
- •\- functional mitral valve pathology
- •\- evolving endocarditis or active endocarditis in the last 3 months
- •\- heavily calcified leaflets
- •\- subjects in whom transesophageal echocardiography is contraindicated
- •\- subjects in whom transseptal catheterisation is contraindicated
- •\- presence of any known life threatening (non\-cardiac major or progressive disease), non\-cardiac disease that will limit the subject's life expectancy to less than one year
- •\- currently participating in the study of an investigational drug or device
- •\- untreated clinically significant CAD requiring revascularisation
- •\- any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Not Applicable
Determinants of the Progression and Outcome of Mitral RegurgitationMitral Valve InsufficiencyNCT01835054Laval University440
Unknown
Not Applicable
The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise CapacityMitral RegurgitationNCT04051411Atlantic Health System30
Completed
Not Applicable
Do patients undergoing coronary artery bypass grafting benefit from concomitant mitral valve surgery?Functional ischemic mitral regurgitationCirculatory SystemMitral (valve) insufficiencyISRCTN33897799Montreal Heart Institute (Canada)58
Terminated
Phase 4
High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical TherapyMitral Valve InsufficiencyNCT02534155University of Zurich294
Completed
Not Applicable
Degenerative Mitral Regurgitation in Intermediate Risk PatientsMitral Valve InsufficiencyMitral RegurgitationNCT02604745Northwestern University13