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Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604110
First Posted: January 30, 2008
Last Update Posted: January 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Clermont-Ferrand
  Purpose
Patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious The aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is hemodynamically favourable.

Condition Intervention Phase
Heart Failure Other: Biventricular pacing post cardiac surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function [ Time Frame: immediately after heart surgery in patients with LVSD ]

Estimated Enrollment: 12
Study Start Date: February 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Biventricular pacing post cardiac surgery
    Determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF<45%), is hemodynamically favourable.
Detailed Description:

Some patients with left ventricular systolic dysfunction (LVSD) have an inefficient pumping function. These patients have been shown to benefit from a device therapy known as biventricular pacing. Biventricular pacing causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure. Cardiac Resynchronization Therapy (CRT) has established itself as a proven therapy for congestive heart failure in adults, patients showing improvement in exercise tolerance, quality of life, and survival.

In cardiac surgery, a significant number of these patients with left ventricular systolic dysfunction require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious Whether biventricular pacing in patients with LVSD improves patient outcomes after heart surgery has not been investigated.

The aim of this crossover trial is to compare conventional ventricular pacing and DDD-biventricular in post operative patients with a pre operative ejection fraction less than 45%, in a prospective randomized setting.

We would like to determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular, immediately after heart surgery in patients with LVSD will improve the heart function.

Immediately after surgery, the patients will receive atrio ventricular conventional right ventricular pacing, or biventricular pacing depending upon the treatment arm that they were randomized to.

The primary end point is a 15 % improvement in index cardiac measured by thermal dilution and/or echocardiography in intensive care unit.

Furthermore, Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), cardiac troponin T (cTnT), will be measured in patients undergoing elective cardiac surgery 12 h, 24 h, 48 h and 72 hours after.

This study is important because of a high probability of clinical benefit.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned CABG and/or valve surgery
  • Left ventricular dysfunction (EF≤ 45%)
  • Age > 18 years
  • able to give written information consent

Exclusion Criteria:

  • Existing permanent pace maker
  • Atrial fibrillation
  • Enrolment in other research protocols
  • Inability to give written informed consent
  • Heart transplant
  • Pre operative cardiovascular instability
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604110


Locations
France
CHU
Clermont-Ferrand, Auvergne, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Charles De Riberolles, Pr
Principal Investigator: Stéphane Combes, Dr
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CHU Clermont-Ferrand, Cardiac surgery center
ClinicalTrials.gov Identifier: NCT00604110     History of Changes
Other Study ID Numbers: CHU-0028
First Submitted: January 17, 2008
First Posted: January 30, 2008
Last Update Posted: January 30, 2008
Last Verified: January 2008

Keywords provided by University Hospital, Clermont-Ferrand:
Biventricular pacing
resynchronisation therapy
cardiac surgery
ejection fraction of less 45%

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases