LVAD in Non Cardiac Transplant Candidates and Non Responders to Resynchronization

NCT ID: NCT01126944

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-12-31

Brief Summary

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.

Conditions

Heart Failure at NYHA Stage III or IV; Non Responders to Resynchronization; Non Candidates for Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

system heart mate II

left ventricular assist device

Group Type: EXPERIMENTAL

heart mate II

Intervention Type: DEVICE

left ventricular assist device

normal medical care

Optimal medical treatment for heart failure according to international guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

heart mate II

left ventricular assist device

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thoratec Europe Ltd

INDUSTRY

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

La Timone Hospital

Marseille, , France

La Pitié Salpétrière Hospital

Paris, , France

University Hospital

Rennes, , France

Klinik für Herz- und Thoraxchirurgie Martin-Luther-Universität

Halle, , Germany

Countries

France; Germany

Other Identifiers

LOC/09-03

Identifier Type: -

Identifier Source: org_study_id