Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation

NCT04293575 | Unknown

• 1 other identifier: MITRABRIDGE280220
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 mitral regurgitation (MR) and end-stage heart failure (HF).

Conditions

Heart Failure; Mitral Regurgitation; End-stage Heart Failure

Keywords

transcatheter mitral valve repair; mitraclip; heart transplantation; LVAD

Outcome Measures

Primary Outcomes (1)

• Composite adverse events rate of all-cause of death, urgent/unplanned HTx or LVAD implantation and first re-hospitalization for HF

  1-year Rate of composite adverse events of all-cause of death, urgent/unplanned HTx or LVAD implantation and first re-hospitalization for HF

  up to 1-year since the MitraClip procedure

Secondary Outcomes (4)

• All-cause of death

  up to 1-year since the MitraClip procedure

• Urgent/unplanned HTx

  up to 1-year since the MitraClip procedure

• Urgent/unplanned LVAD

  up to 1-year since the MitraClip procedure

• First re-hospitalization for HF

  up to 1-year since the MitraClip procedure

Other Outcomes (1)

• Rate of patients going for elective HTx, entering (or remaining) in the waiting list and having no more indication to HTx (delisting) because of significant echocardiographic and/or clinical improvements during the entire observational period.

  up to 1-year since the MitraClip procedure

Study Arms (3)

In list group

patients on active heart transplantation (HTx) list with a low likelihood to receive a donation shortly (e.g. for body weight or blood group)

Device: MitraClip

Bridge to decision "BTD" group

patients suitable for HTx, but that were still waiting for clinical decision

Device: MitraClip

(Bridge to candidacy "BTC" group)

patients who could not be yet in list for HTx 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)

Device: MitraClip

Interventions

MitraClip DEVICE

transcatheter MitraClip device (Abbott Vascular, Santa Clara, California)

(Bridge to candidacy "BTC" group); Bridge to decision "BTD" group; In list group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All potential candidates for HTx treated with MitraClip in the contest of a pre-specified bridge strategy.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

Cosmo Godino

Milan, 20131, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: June 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: June 30, 2021
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months

Locations

IT (1)