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

September 13, 2005
October 5, 2006
April 2003
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Z-ratio
Same as current
Complete list of historical versions of study NCT00187265 on ClinicalTrials.gov Archive Site
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Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients
Triple Resynchronization in Paced Heart Failure Patients

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).

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Heart Failure
  • Ventricular Dyssynchrony
Device: Cardiac Resynchronization Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2005
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00187265
CR03005HF
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St. Jude Medical
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Principal Investigator: Jean-Claude Daubert CHU Pontchaillou Rennes France
St. Jude Medical
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP