LVAD in Non Cardiac Transplant Candidates and Non Responders to Resynchronization (CHECKMATE)
|ClinicalTrials.gov Identifier: NCT01126944|
Recruitment Status : Withdrawn (No patients recruted since recruiting is open)
First Posted : May 20, 2010
Last Update Posted : July 4, 2011
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 or disease||Intervention/treatment||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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Congestive Heart Failure Through the Evaluation of Cardiac Resynchronization Non-responders and Mechanical Assistance Therapy|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||December 2013|
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
- quality of life : minnesota living with heart failure [ Time Frame: one year ]
- 6 mn walk test [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126944
|La Timone Hospital|
|La Pitié Salpétrière Hospital|
|Klinik für Herz- und Thoraxchirurgie Martin-Luther-Universität|