Status:
UNKNOWN
Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation
Lead Sponsor:
Scientific Institute San Raffaele
Conditions:
Heart Failure
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to report medium-term outcomes after the use of transcatheter mitral valve repair (TMVR) with MitraClip as a bridge therapy to heart transplantation (HTx) in patients with mit...
Detailed Description
Background: Heart transplantation (HTx) is the most effective therapeutic option for patients with advanced or end-stage chronic heart failure (HF). However, the increasing number of patients with ref...
Eligibility Criteria
Inclusion
- patients with chronic end-stage HF \[New York Heart Association (NYHA) III or IV and/or left ventricular ejection fraction (LVEF) ≤35%\] and concomitant moderate-severe or severe MR being potential candidates for HTx.
- patients on active HTx list (In list group, "pure bridge") with a low likelihood to receive a donation shortly (e.g. for body weight or blood group);
- patients suitable for HTx, but that were still waiting for clinical decision (Bridge to decision, "BTD" group);
- patients who could not be yet in list for HTx (Bridge to candidacy, "BTC" group) because of concomitant, potentially reversible, contraindications such as severe pulmonary hypertension, elevated pulmonary-vascular-resistance, unsatisfactory response to vasodilator challenge or other causes resulting in a prohibitive peri-procedural risk (as pre-transplant body mass index \[BMI\] \>35 kg/m2, severe renal dysfunction with creatinine clearance \<30 mL/min) and other reasons (current alcohol, tobacco or drug abuse, poor social support, non-residents)
Exclusion
- patients with mitral valve anatomy not suitable for percutaneous mitral valve repair using the MitraClip device
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04293575
Start Date
June 1 2018
End Date
June 30 2021
Last Update
March 26 2020
Active Locations (1)
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1
Cosmo Godino
Milan, Italy, 20131