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

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ClinicalTrials.gov Identifier: NCT04293575
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Cosmo Godino, Scientific Institute San Raffaele

Tracking Information
First Submitted Date February 28, 2020
First Posted Date March 3, 2020
Last Update Posted Date March 26, 2020
Actual Study Start Date June 1, 2018
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2020)
Composite adverse events rate of all-cause of death, urgent/unplanned HTx or LVAD implantation and first re-hospitalization for HF [ Time Frame: up to 1-year since the MitraClip procedure ]
1-year Rate of composite adverse events of all-cause of death, urgent/unplanned HTx or LVAD implantation and first re-hospitalization for HF
Original Primary Outcome Measures
 (submitted: March 2, 2020)
1-year composite adverse events rate of all-cause of death, urgent/unplanned HTx or LVAD implantation and first re-hospitalization for HF [ Time Frame: up to 1-year since the MitraClip procedure ]
1-year composite adverse events rate of all-cause of death, urgent/unplanned HTx or LVAD implantation and first re-hospitalization for HF
Change History
Current Secondary Outcome Measures
 (submitted: March 3, 2020)
  • All-cause of death [ Time Frame: up to 1-year since the MitraClip procedure ]
    Rate of all-cause of death
  • Urgent/unplanned HTx [ Time Frame: up to 1-year since the MitraClip procedure ]
    Rate of urgent/unplanned HTx
  • Urgent/unplanned LVAD [ Time Frame: up to 1-year since the MitraClip procedure ]
    Rate of urgent/unplanned LVAD
  • First re-hospitalization for HF [ Time Frame: up to 1-year since the MitraClip procedure ]
    Rate of first re-hospitalization for HF
Original Secondary Outcome Measures
 (submitted: March 2, 2020)
  • All-cause of death [ Time Frame: up to 1-year since the MitraClip procedure ]
    all-cause of death
  • Urgent/unplanned HTx [ Time Frame: up to 1-year since the MitraClip procedure ]
    urgent/unplanned HTx
  • Urgent/unplanned LVAD [ Time Frame: up to 1-year since the MitraClip procedure ]
    urgent/unplanned LVAD
  • First re-hospitalization for HF [ Time Frame: up to 1-year since the MitraClip procedure ]
    first re-hospitalization for HF
Current Other Pre-specified Outcome Measures
 (submitted: March 3, 2020)
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. [ Time Frame: up to 1-year since the MitraClip procedure ]
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.
Original Other Pre-specified Outcome Measures
 (submitted: March 2, 2020)
ates 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. [ Time Frame: up to 1-year since the MitraClip procedure ]
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.
 
Descriptive Information
Brief Title Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation
Official Title MitraBridge Registry
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).
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All potential candidates for HTx treated with MitraClip in the contest of a pre-specified bridge strategy.
Condition
  • Heart Failure
  • Mitral Regurgitation
  • End-stage Heart Failure
Intervention Device: MitraClip
transcatheter MitraClip device (Abbott Vascular, Santa Clara, California)
Study Groups/Cohorts
  • 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)
    Intervention: Device: MitraClip
  • Bridge to decision "BTD" group
    patients suitable for HTx, but that were still waiting for clinical decision
    Intervention: 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)
    Intervention: Device: MitraClip
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 2, 2020)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2021
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04293575
Other Study ID Numbers MITRABRIDGE280220
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 6 months
Responsible Party Cosmo Godino, Scientific Institute San Raffaele
Study Sponsor Scientific Institute San Raffaele
Collaborators Not Provided
Investigators Not Provided
PRS Account Scientific Institute San Raffaele
Verification Date March 2020