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CompletedNCT00187265Updated Feb 4, 2019

Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

An interventional study of Cardiac Resynchronization Therapy in Heart Failure and Ventricular Dyssynchrony, sponsored by Abbott Medical Devices. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Heart Failure
  • Ventricular Dyssynchrony

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

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Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single

Interventions

  • DeviceCardiac Resynchronization Therapy
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What researchers measure

Primary outcomes

  1. Z-ratio

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Study locations

1 site
  • Department of Cardiology - CHU Pontchaillou
    Rennes, 35011, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00187265
Lead sponsor
Abbott Medical Devices
First posted
Sep 16, 2005
Start date
Apr 2003
Completion
Oct 2005
Last update
Feb 4, 2019

Study contacts

Jean-Claude Daubert
principal investigator · CHU Pontchaillou Rennes France
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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