Evaluation of Resynchronization Therapy for Heart Failure (EARTH)

NCT ID: NCT00901212

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2010-02-28

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: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LV Pacing

left univentricular pacing

Group Type: ACTIVE_COMPARATOR

Device programming

Intervention Type: DEVICE

6-month period

BV Pacing

biventricular pacing

Group Type: ACTIVE_COMPARATOR

Device programming

Intervention Type: DEVICE

6-month period

Interventions

Device programming

6-month period

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Patient must answer "yes"

1. Does the patient require an ICD or an ICD replacement?

2. Does the patient have a documented LVEF less than or equal to 35% measured in the previous 6 months (without major concomitant clinical event)?

3. Does the patient have a QRS duration < 120 ms?

4. Is the patient in sinus rhythm?

5. Was the six-minute walk test distance less than 400 meters and limited by heart failure symptoms?

Exclusion Criteria

1. Does the patient have:

• Indication for permanent ventricular pacing?
• Chronotropic insufficiency?
• Second or third degree AV block, either persistent or intermittent?
• A pacemaker or an ICD which is paced in ventricular chamber more than 5% of the time?

2. Does the patient have a reversible cause of LV dysfunction such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)?

3. Did the patient have myocardial infarction or cardiac surgery in the 6 weeks preceding the pre-implant visit?

4. Does the patient have a moderate or severe cardiac valve stenosis?

5. Is the patient's capacity to walk is limited by reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthritis)?

6. Does the patient have severe coexisting illnesses making survival > 6 months unlikely?

7. Is the patient pregnant and/or nursing?

8. Is the patient unable or unwilling to consent or to comply with follow-up requirements?

9. Is the patient participating in another clinical study potentially interfering with the present trial?

10. Does the patient have a resynchronization system in place?

• 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

Bernard Thibault

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernard MD, Thibault

Role: STUDY_CHAIR

Montreal Heart Institute Research Center

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

St-Paul's Hospital

Vancouver, British Columbia, Canada

QEII Health Sciences Centre

Halifax, Nova Scotia, 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

Montreal Heart Institute

Montreal, Quebec, Canada

CHUM-Hôpital Hotel-Dieu

Montreal, Quebec, Canada

Sacre-Coeur Hospital

Montreal, Quebec, Canada

Institut Univ de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Countries

Canada

References

Legris V, Thibault B, Dupuis J, White M, Asgar AW, Fortier A, Pitre C, Bouabdallaoui N, Henri C, O'Meara E, Ducharme A; EARTH Investigators. Right ventricular function and its coupling to pulmonary circulation predicts exercise tolerance in systolic heart failure. ESC Heart Fail. 2022 Feb;9(1):450-464. doi: 10.1002/ehf2.13726. Epub 2021 Dec 24.

Reference Type: DERIVED

PMID: 34953062 (View on PubMed)

Thibault B, Ducharme A, Harel F, White M, O'Meara E, Guertin MC, Lavoie J, Frasure-Smith N, Dubuc M, Guerra P, Macle L, Rivard L, Roy D, Talajic M, Khairy P; Evaluation of Resynchronization Therapy for Heart Failure (GREATER-EARTH) Investigators. Left ventricular versus simultaneous biventricular pacing in patients with heart failure and a QRS complex >/=120 milliseconds. Circulation. 2011 Dec 20;124(25):2874-81. doi: 10.1161/CIRCULATIONAHA.111.032904. Epub 2011 Nov 21.

Reference Type: DERIVED

PMID: 22104549 (View on PubMed)

Thibault B, Harel F, Ducharme A, White M, Frasure-Smith N, Roy D, Philippon F, Dorian P, Talajic M, Dubuc M, Gagne P, Guerra PG, Macle L, Rivard L, Khairy P. Evaluation of resynchronization therapy for heart failure in patients with a QRS duration greater than 120 ms (GREATER-EARTH) trial: rationale, design, and baseline characteristics. Can J Cardiol. 2011 Nov-Dec;27(6):779-86. doi: 10.1016/j.cjca.2011.03.010. Epub 2011 Jul 24.

Reference Type: DERIVED

PMID: 21791363 (View on PubMed)

Other Identifiers

42560370

Identifier Type: -

Identifier Source: secondary_id

UCT-67914 (Greater Earth)

Identifier Type: -

Identifier Source: org_study_id