Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 heart-failure
Started Feb 2008
Shorter than P25 for phase_3 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2008
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedJanuary 30, 2008
January 1, 2008
7 months
January 17, 2008
January 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function
immediately after heart surgery in patients with LVSD
Interventions
Determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF\<45%), is hemodynamically favourable.
Eligibility Criteria
You may qualify if:
- Planned CABG and/or valve surgery
- Left ventricular dysfunction (EF≤ 45%)
- Age \> 18 years
- able to give written information consent
You may not qualify if:
- Existing permanent pace maker
- Atrial fibrillation
- Enrolment in other research protocols
- Inability to give written informed consent
- Heart transplant
- Pre operative cardiovascular instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU
Clermont-Ferrand, Auvergne, 63003, France
Related Publications (1)
Forestier C, Guelon D, Cluytens V, Gillart T, Sirot J, De Champs C. Oral probiotic and prevention of Pseudomonas aeruginosa infections: a randomized, double-blind, placebo-controlled pilot study in intensive care unit patients. Crit Care. 2008;12(3):R69. doi: 10.1186/cc6907. Epub 2008 May 20.
PMID: 18489775DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles De Riberolles, Pr
- PRINCIPAL INVESTIGATOR
Stéphane Combes, Dr
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 17, 2008
First Posted
January 30, 2008
Study Start
February 1, 2008
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
January 30, 2008
Record last verified: 2008-01