Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187265
First received: September 13, 2005
Last updated: October 5, 2006
Last verified: April 2006
  Purpose

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 Intervention
Heart Failure
Ventricular Dyssynchrony
Device: Cardiac Resynchronization Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Triple Resynchronization in Paced Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Z-ratio

Study Start Date: April 2003
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00187265     History of Changes
Other Study ID Numbers: CR03005HF
Study First Received: September 13, 2005
Last Updated: October 5, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014