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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

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).

Condition or disease Intervention/treatment
Heart Failure Mitral Regurgitation End-stage Heart Failure 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: MitraBridge Registry
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. All-cause of death [ Time Frame: up to 1-year since the MitraClip procedure ]
    Rate of all-cause of death

  2. Urgent/unplanned HTx [ Time Frame: up to 1-year since the MitraClip procedure ]
    Rate of urgent/unplanned HTx

  3. Urgent/unplanned LVAD [ Time Frame: up to 1-year since the MitraClip procedure ]
    Rate of urgent/unplanned LVAD

  4. First re-hospitalization for HF [ Time Frame: up to 1-year since the MitraClip procedure ]
    Rate of first re-hospitalization for HF


Other Outcome Measures:
  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. [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293575


Locations
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Italy
Cosmo Godino Recruiting
Milan, Italy, 20131
Contact: COSMO GODINO, MD    +393478497733    godino.cosmo@hsr.it   
Sponsors and Collaborators
Scientific Institute San Raffaele
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Responsible Party: Cosmo Godino, Principal Investigator, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier: NCT04293575    
Other Study ID Numbers: MITRABRIDGE280220
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 6 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cosmo Godino, Scientific Institute San Raffaele:
transcatheter mitral valve repair
mitraclip
heart transplantation
LVAD
Additional relevant MeSH terms:
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Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases