Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

Heart Failure Clinical Trial

Official title:

Triple Resynchronization in Paced Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187265
• Other study ID #: CR03005HF
• Status: Completed
• Phase: N/A
• Start date: April 2003
• Est. completion date: October 2005

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Ventricular Dyssynchrony

Intervention

Device:
• Cardiac Resynchronization Therapy

Locations

Country	Name	City	State
France	Department of Cardiology - CHU Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Z-ratio