Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation (MitraBridge)

MitraBridge Registry

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).

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Mitral Regurgitation; End-stage Heart Failure
• Intervention / Treatment: Device: MitraClip

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 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 the waiting period, several pharmacological and mechanical bridging therapies have been developed. Anyway, limited data are now available regarding the use of MitraClip treatment as bridge strategy in patients with severe mitral regurgitation (MR) and end-stage HF waiting for HTx.

Methods: The MitraBridge registry is an observational, multicenter, international registry including all consecutive 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 who were potential candidates for HTx, that were treated with MitraClip in the contest of a pre-specified bridge strategy.

According to the clinical conditions present at the time of the MitraClip procedure, patients are classified in:

1. patients on active HTx list (In list group, "pure bridge") with a rapidly progressive disease and a low likelihood to receive a donation shortly;
2. patients waiting for clinical decision (Bridge to decision "BTD" group), also including unstable patients during the screening for HTx;
3. patients who could not be listed for HTx (Not in list group, MitraClip as "bridge to candidacy") because of concomitant, potentially reversible, contraindications (e.g. severe pulmonary hypertension, elevated pulmonary-vascular-resistance).

The registry was initiated in June 2018 without the support of any external funding and was designed to involve centers across the world that have experience with transcatheter MitraClip device (Abbott Vascular, Santa Clara, California).

Study endpoints. The primary endpoint: 1-year composite adverse events rate of all-cause of death, urgent/unplanned HTx or LVAD implantation and first re-hospitalization for HF.

As exploratory outcomes: individual components of the primary endpoint.

Moreover, the investigators described the clinical status of patients at the time of last available follow-up, in order to report the rates 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.

Mitral Valve Academic Research Consortium (MVARC) criteria are used to define procedural success and composite events 12.

Follow-up data will be collected for patients at 1 month and 1-year and then according to the time frame elapsed from the index procedure to data lock for present analysis.

Patients that did not implant any clip during the index procedure were not included in the follow-up. For patients who underwent HTx or LVAD implantation, the follow-up time was stopped at the date of transplant or mechanical device placement.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20131
    • Recruiting
    • Cosmo Godino
    • Contact: COSMO GODINO, MD; Phone Number: +393478497733; Email: godino.cosmo@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; transcatheter MitraClip device (Abbott Vascular, Santa Clara, California)
Bridge to decision "BTD" group; patients suitable for HTx, but that were still waiting for clinical decision	Device: MitraClip; transcatheter MitraClip device (Abbott Vascular, Santa Clara, California)
(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; transcatheter MitraClip device (Abbott Vascular, Santa Clara, California)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause of death	Rate of all-cause of death	up to 1-year since the MitraClip procedure
Urgent/unplanned HTx	Rate of urgent/unplanned HTx	up to 1-year since the MitraClip procedure
Urgent/unplanned LVAD	Rate of urgent/unplanned LVAD	up to 1-year since the MitraClip procedure
First re-hospitalization for HF	Rate of first re-hospitalization for HF	up to 1-year since the MitraClip procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Rate of patients going for elective HTx, entering (or remaining) in the waiting list and 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

Collaborators and Investigators

• Sponsor: Scientific Institute San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: heart transplantation; LVAD; transcatheter mitral valve repair; mitraclip
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Mitral Valve Insufficiency
• Other Study ID Numbers: MITRABRIDGE280220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 6 months
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No