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

This study has been withdrawn prior to enrollment.
(No patients recruted since recruiting is open)
Sponsor:
Collaborator:
Thoratec Europe Ltd
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01126944
First received: May 18, 2010
Last updated: July 1, 2011
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure at NYHA Stage III or IV
Non Responders to Resynchronization
Non Candidates for Transplantation
 Device: heart mate II
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Congestive Heart Failure Through the Evaluation of Cardiac Resynchronization Non-responders and Mechanical Assistance Therapy

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • quality of life : minnesota living with heart failure [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 mn walk test [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126944

Locations
France
La Timone Hospital
Marseille, France
La Pitié Salpétrière Hospital
Paris, France
University Hospital
Rennes, France
Germany
Klinik für Herz- und Thoraxchirurgie Martin-Luther-Universität
Halle, Germany
Sponsors and Collaborators
Rennes University Hospital
Thoratec Europe Ltd
  More Information

No publications provided

Responsible Party: Erwan Flecher, MD, Rennes University hospital
ClinicalTrials.gov Identifier: NCT01126944     History of Changes
Other Study ID Numbers: LOC/09-03
Study First Received: May 18, 2010
Last Updated: July 1, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
heart failure
resynchronization
left ventricular assist device

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013