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Completed

NCT Number: NCT00187265

Trip HF Study: Triple Resynchronization in Paced Heeart 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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Ventricular Dyssynchrony

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology - CHU Pontchaillou

Rennes, 35011, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiac resynchronization therapy

Device

Primary outcomes

  1. Z-ratio

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Triple Resynchronization in Paced Heart Failure Patients

Important dates

Study start
2003
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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