Evaluation of Resynchronization Therapy for Heart Failure

NCT ID: NCT00900549

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2011-07-31

Brief Summary

Heart failure is a major health problem in Canada. Recent advances in medical and device therapy have helped to reduce the morbidity and mortality of patients with this problem. Among these treatments, cardiac resynchronization therapy (CRT) has very recently been shown to be effective to improve functional class, quality of life and exercise tolerance of the patients with the most severe symptoms of heart failure and a prolonged duration of the QRS on the 12-lead Electrocardiography (ECG).

Detailed Description

Resynchronization of the failing ventricle is currently achieved by pacing the left and right ventricles simultaneously with specialized electrodes and a cardiac stimulator. However, controversy persists concerning the optimal configuration for cardiac pacing in these patients. Right ventricular pacing alone has been shown to be deleterious in some patient populations. The benefits of biventricular pacing in heart failure patients may be due primarily to left ventricular stimulation and may, in some patients, be decreased by the presence of simultaneous RV stimulation. Preliminary data from our own animal work suggest that in the majority of cases, LV stimulation alone is better than RV stimulation, and that BiV stimulation represents an intermediary situation between LV and RV stimulation.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CRT

Group Type: EXPERIMENTAL

CRT on

Intervention Type: DEVICE

12 months

No CRT

Group Type: SHAM_COMPARATOR

CRT off

Intervention Type: DEVICE

12-month

Interventions

CRT on

12 months

Intervention Type: DEVICE

CRT off

12-month

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The patients are eligible if they undergo an ICD implantation or replacement
• They have a documented LVEF ≤ 35% measured in the previous 6 months (without major clinical subsequent event, such as heart surgery, since the LVEF measurement)
• If measured by echocardiography, the LV end-diastolic diameter must be ≥ 60 mm
• The duration of the QRS is < 120 ms
• They are in sinus rhythm
• They cannot walk more than 400 meters during the screening 6-minute walk test (the patients must be limited by heart failure symptoms)

Exclusion Criteria

• Patients with an indication for permanent ventricular pacing or with chronotropic insufficiency defined as follow:

• Any condition where the treating physician believes it would not be acceptable for the patient to have his device NOT programmed with the SENSOR at ON for the duration of the study
• Second or third degree AV block, either persistent or intermittent
• Patients with a pacemaker or an ICD who are paced in the ventricular chamber more than 5% of the time
• Patients with LV dysfunction associated with a reversible cause such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)
• Patients who had a myocardial infarction within the past 6 weeks* defined by 2 of the 3 following conditions:

• Prolonged chest pain
• ECG changes suggesting of AMI
• Cardiac enzymes elevation more than twice the local upper limit of normal)
• Patients who had cardiac surgery within the past 6 weeks*
• Patients with moderate or severe cardiac valve stenosis (aortic, mitral, pulmonary or tricuspid)
• Patients with an inability or a limitation to walk for reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthrosis)
• Patients with severe coexisting illnesses making survival > 6 months unlikely
• Patients who are pregnant and/or nursing.
• Patients with inability or unwillingness to consent or comply with follow-up requirements
• Patients participating in another study

The 6-week period is calculated prior to the beginning of the baseline evaluation and not the implant procedure itself. This difference comes from the fact that the protocol includes a delay of 2 to 8 weeks between the implant procedure and the actual beginning of the patient's evaluation.

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

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Montreal Heart Institute

Principal Investigators

Bernard Thibault, MD

Role: STUDY_CHAIR

Montreal Heart Institute

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Sunnybrook & Women's Hospital

Toronto, Ontario, Canada

St-Michael's Hospital

Toronto, Ontario, Canada

CHUS-Fleurimont

Fleurimont, Quebec, Canada

CHUM-Hôpital Hotel-Dieu

Montreal, Quebec, Canada

Sacre-Coeur Hospital

Montreal, Quebec, Canada

Montreal Heart Institute Research Center

Montreal, Quebec, Canada

Institut Univ de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Countries

Canada

References

Thibault B, Harel F, Ducharme A, White M, Ellenbogen KA, Frasure-Smith N, Roy D, Philippon F, Dorian P, Talajic M, Dubuc M, Guerra PG, Macle L, Rivard L, Andrade J, Khairy P; LESSER-EARTH Investigators. Cardiac resynchronization therapy in patients with heart failure and a QRS complex <120 milliseconds: the Evaluation of Resynchronization Therapy for Heart Failure (LESSER-EARTH) trial. Circulation. 2013 Feb 26;127(8):873-81. doi: 10.1161/CIRCULATIONAHA.112.001239. Epub 2013 Feb 6.

Reference Type: DERIVED

PMID: 23388213 (View on PubMed)

Other Identifiers

ISRCTN 42560370

Identifier Type: -

Identifier Source: secondary_id

UCT67914 (Lesser Earth)

Identifier Type: -

Identifier Source: org_study_id