Heart Failure Clinical Trial
Official title:
Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
Verified date | January 2008 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 12 |
Est. completion date | October 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU | Clermont-Ferrand | Auvergne |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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