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Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

Primary Purpose

Heart Failure, Ventricular Dyssynchrony

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiology - CHU Pontchaillou

Outcomes

Primary Outcome Measures

Z-ratio

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00187265
Brief Title
Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients
Official Title
Triple Resynchronization in Paced Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Medical Devices

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Dyssynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy
Primary Outcome Measure Information:
Title
Z-ratio

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude Daubert
Organizational Affiliation
CHU Pontchaillou Rennes France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology - CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35011
Country
France

12. IPD Sharing Statement

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Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

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