CClinicalTrials.gg
CompletedNCT00901212EARTHUpdated May 8, 2012

Evaluation of Resynchronization Therapy for Heart Failure (EARTH)

A Phase 4 interventional study of Device programming in Heart Failure, sponsored by Montreal Heart Institute. Completed at 11 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-08.

Sponsored by Montreal Heart Institute · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Heart Failure

Browse trials for

Keywords

  • Heart Failure
  • resynchronisation
  • ICD
03

In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

Patient must have answered "NO" to all of the 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?
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    LV Pacing

    left univentricular pacing

    Device: Device programming

  • Active comparator
    BV Pacing

    biventricular pacing

    Device: Device programming

Interventions

  • DeviceDevice programming

    6-month period

06

What researchers measure

Primary outcomes

  1. The primary endpoint is total exercise duration at a constant submaximal load (ETT submaximal load is defined as 75% of peak exercise during the baseline metabolic evaluation)

    Time frame: one year

Secondary outcomes

  1. Clinical, electrical, echocardiographic, MUGA scan endpoints, Neuro-hormones

    Time frame: one year

07

Study locations

11 sites
  • University of Alberta Hospital
    Edmonton, Alberta T6G 2B7, Canada
  • St-Paul's Hospital
    Vancouver, British Columbia V6Z 1Y6, Canada
  • QEII Health Sciences Centre
    Halifax, Nova Scotia B3H 3A7, Canada
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y 4W7, Canada
  • Sunnybrook & Women's Hospital
    Toronto, Ontario M4N 3M5, Canada
  • St-Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
  • CHUS-Fleurimont
    Fleurimont, Quebec J1H 5N4, Canada
  • Montreal Heart Institute
    Montreal, Quebec H1T1C8, Canada
  • CHUM-Hôpital Hotel-Dieu
    Montréal, Quebec H2W 1T8, Canada
  • Sacre-Coeur Hospital
    Montréal, Quebec H4J 1C5, Canada
  • Institut Univ de Cardiologie et de Pneumologie de Québec
    Québec, Quebec G1V 4G5, Canada
08

References and documents

Publications

  • 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. PubMed 34953062 ↗
  • 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. PubMed 22104549 ↗
  • 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. PubMed 21791363 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00901212
Lead sponsor
Montreal Heart Institute
Collaborators
Abbott Medical Devices, Canadian Institutes of Health Research (CIHR)
Responsible party
Bernard Thibault (MD, Montreal Heart Institute) — Principal investigator
First posted
May 13, 2009
Start date
Oct 2003
Primary completion
Feb 2010
Completion
Feb 2010
Last update
May 8, 2012

Study contacts

Bernard MD, Thibault
study chair · Montreal Heart Institute Research Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion