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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00604110
First received: January 17, 2008
Last updated: January 29, 2008
Last verified: January 2008
History of Changes
  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 Blind (Subject)
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Clermont-Ferrand

Additional 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
Study First Received: January 17, 2008
Last Updated: January 29, 2008
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013