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Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

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ClinicalTrials.gov Identifier: NCT00187265
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 6, 2006
Sponsor:
Information provided by:
St. Jude Medical

Brief Summary:
The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).

Condition or disease Intervention/treatment Phase
Heart Failure Ventricular Dyssynchrony Device: Cardiac Resynchronization Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Triple Resynchronization in Paced Heart Failure Patients
Study Start Date : April 2003
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources




Primary Outcome Measures :
  1. Z-ratio


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• NYHA class III–IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure for 1 month.

The medical treatment must include a 40 mg/day minimum dose of furosemide (or equivalent);

  • Permanent atrial fibrillation (AF);
  • Left ventricular ejection fraction (LVEF) ≤ 35%;
  • Indication for a pacemaker implantation for a permanent and symptomatic bradycardia, or already implanted pacemaker under the condition that leads positioning corresponds to the criteria described in the protocol;
  • Aortic pre-ejection delay at least equal to 140 ms.

Exclusion Criteria:

  • Indication for a cardiac defibrillator;
  • Having presented a myocardial infarct within the previous 3 months;
  • Having undergone cardiac surgery or coronary revascularization procedure within the previous 3 months, or being scheduled for such procedures;
  • Presenting chronic pulmonary insufficiency;
  • Patients whose congestive heart failure requires the use of an intravenous inotropic support;
  • Presenting a dysthyreosis;
  • Having a life expectancy of less than one year, for other reasons than the congestive heart failure;
  • Unable to be followed-up in the scope of the study for geographical reasons;
  • Having refused to give their consent;
  • Minors (age < 18 years) and pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187265


Locations
France
Department of Cardiology - CHU Pontchaillou
Rennes, France, 35011
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Jean-Claude Daubert CHU Pontchaillou Rennes France

ClinicalTrials.gov Identifier: NCT00187265     History of Changes
Other Study ID Numbers: CR03005HF
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 6, 2006
Last Verified: April 2006

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases