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
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 April 17, 2014