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Search / Trial NCT04293575

Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation

Launched by SCIENTIFIC INSTITUTE SAN RAFFAELE · Mar 2, 2020

Trial Information

Current as of June 25, 2025

Unknown status

Keywords

Transcatheter Mitral Valve Repair Mitraclip Heart Transplantation Lvad

ClinConnect Summary

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 refractory chronic HF and the declining willingness for organ donation, have resulted in expanded waiting lists and prolonged waiting times for patients listed for HTx. Furthermore, more than 60% of patients are transplanted in high-urgency status, leaving little chance for patients listed for less urgent transplantation. In order to improve the general conditions of these latter patients during t...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • patients with mitral valve anatomy not suitable for percutaneous mitral valve repair using the MitraClip device

About Scientific Institute San Raffaele

The Scientific Institute San Raffaele is a leading research and clinical care institution based in Milan, Italy, dedicated to advancing healthcare through innovative scientific research and high-quality patient care. With a strong emphasis on translational medicine, the institute integrates cutting-edge research with clinical applications, fostering collaboration among scientists, clinicians, and industry partners. San Raffaele is committed to enhancing the understanding of complex diseases and developing novel therapeutic strategies, thereby contributing to the improvement of global health outcomes. Its state-of-the-art facilities and multidisciplinary approach position the institute as a key player in the landscape of clinical trials and biomedical research.

Locations

Milan, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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