LVAD in Non Cardiac Transplant Candidates and Non Responders to Resynchronization (CHECKMATE)

April 11, 2023 updated by: Rennes University Hospital

Study of Congestive Heart Failure Through the Evaluation of Cardiac Resynchronization Non-responders and Mechanical Assistance Therapy

The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease. Heart transplantation remains the reference treatment for the terminal stage of the disease but although this is an effective therapy, it does engender ethical, social, economic and legal problems. It also requires irreproachable and costly logistics, immuno-suppressor treatment and a lifetime of follow-ups. In particular, the number of donors has been going down steadily for several years in most countries which offer a heart transplant programme and some patients cannot take advantage of being added to a waiting list for a graft (age, co-morbidities…).

It is in this context that, alongside the medical treatments for cardiac insufficiency, other therapeutic strategies were developed, including resynchronization and long-term mechanical circulatory support. The progress made in resynchronization is at several levels: better understanding of the action mechanisms, the development and improvement of equipment specifically dedicated to resynchronization and prospective and randomized clinical trials which have scientifically validated this technique.

Simultaneously, many studies were published evaluating long term support with mechanical circulatory support (MCS), excluding light devices, as a bridge to transplant or an alternative to a transplant. It is also recognized that mechanical circulatory support with a new generation of continuous flow assist device improved the quality of life and functional capacity, with a reduced risk of device failure and infrequent need for replacement.

The "Achilles heel" of cardiac resynchronization remains the 20 to 40% of patients who respond barely or not at all. Among this population of patients, some are not candidates for a transplantation and long-term mechanical circulatory support by axial pump is an alternative to be considered. We elaborated an original randomized pilot study for these patients in order to evaluate their survival and their quality of life, to define if they should be proposed a left ventricular assist device (LVAD)or not.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • La Timone Hospital
      • Paris, France
        • La Pitié Salpêtrière Hospital
      • Rennes, France
        • University Hospital
  • Germany
      • Halle, Germany
        • Klinik für Herz- und Thoraxchirurgie Martin-Luther-Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with heart failure class III or IV NYHA
  • LVEF < 35%
  • resynchronization for at least 6 months
  • non eligibility for cardiac transplant
  • operability and psychological criteria assessed

Exclusion Criteria:

  • Patients incapable of understanding the proposed procedure, its risks and potential benefits or the consequences engendered by the permanent implanting of a left ventricular assist device
  • Patients on mechanical circulatory support, including an intra-aortic counter-pulsion balloon, at the time of randomisation
  • Patients with acute decompensated cardiac insufficiency at the time of randomisation
  • Patients whose body surface area is below 1.2m²
  • Patients with a mechanical cardiac valve
  • Patients requiring associated aortic or mitral surgery
  • Patients with an active uncontrolled infection
  • Patients with a severe pulmonary respiratory pathology
  • Patients with contra-indications for or an intolerance to anti-coagulants or platelet anti-aggregants
  • Presence of risk factors or indicators of visceral failure (severe COPD, renal insufficiency with dialysis, hepatic insufficiency with cholestasis…)
  • Patients with a Lietz/Miller operating mortality score ≥ "high risk"
  • Patients with an elevated risk of an embolism and atrial intra-cardiac thrombus
  • Severe right ventricular failure (echography and right cardiac catheter examination) with the probable need for right ventricular mechanical assistance
  • Patients who are candidates for coronary revascularisation
  • Participation in another study which may interact with the proposed clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: system heart mate II
left ventricular assist device
Device: heart mate II
left ventricular assist device
No Intervention: normal medical care
Optimal medical treatment for heart failure according to international guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life : minnesota living with heart failure
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
6 mn walk test
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Thoratec Europe Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOC/09-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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