- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00187265
Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients
February 1, 2019 updated by: Abbott Medical Devices
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rennes, France, 35011
- Department of Cardiology - CHU Pontchaillou
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Z-ratio
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Claude Daubert, CHU Pontchaillou Rennes France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion
October 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 16, 2005
Study Record Updates
Last Update Posted (ACTUAL)
February 4, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR03005HF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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