Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00417092
Other study ID # UL 04-156
Secondary ID
Status Completed
Phase N/A
First received December 28, 2006
Last updated September 21, 2007
Start date December 2006
Est. completion date September 2007

Study information

Verified date September 2007
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine which pacing mode after coronary artery bypass grafting in patients with reduced left ventricular function is hemodynamically favorable.


Description:

Patients with severely reduced left ventricular function undergoing coronary artery bypass grafting (CABG) 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 whereas biventricular pacing improves cardiac output in patients with severely reduced left ventricular function and bundle branch block. The purpose of this study is to compare DDD-right ventricular, DDD-biventricular and AAI pacing in CABG patients with an ejection fraction less than 40% in a prospective randomized setting.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective or urgent coronary artery bypass grafting

- Preoperative ejection fraction less than 40%

Exclusion Criteria:

- Existing permanent pacemaker or ICD

- Concomitant valve surgery

- Preoperative cardiovascular instability requiring intubation or IABP use

- Chronic renal failure requiring dialysis

- Failure to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Intervention

Procedure:
Postoperative Pacing


Locations

Country Name City State
Germany University Hospital Schleswig Holstein, Campus Luebeck, Cardiac Surgery Luebeck Schleswig Holstein

Sponsors (1)

Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of Intensive Care Treatment
Secondary 30 day mortality
Secondary Major adverse events
Secondary Duration of Hospital Stay
Secondary Hemodynamic parameters
Secondary Inotrope use
Secondary Atrial fibrillation
Secondary Ventricular tachycardia / ventricular fibrillation
Secondary Renal function
Secondary Stability of pacing wires
See also
  Status Clinical Trial Phase
Recruiting NCT03235323 - Efficacy of External CounterPulsation for Postoperative Coronary Artery Bypass Grafting Patients N/A
Completed NCT05036044 - Stroke and Carotid-Cerebral Vascular Disease After CABG
Recruiting NCT05010460 - Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting Phase 2
Completed NCT03622671 - Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting N/A
Completed NCT00400790 - Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane N/A
Not yet recruiting NCT03275220 - Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Completed NCT00489827 - Glutamate for Metabolic Intervention in Coronary Surgery Phase 3
Completed NCT04591119 - Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery N/A
Active, not recruiting NCT03908593 - Proton Pump Inhibitor Preventing Upper Gastrointestinal Injury In Patients On Dual Antiplatelet Therapy After CABG Phase 4
Recruiting NCT03774342 - The Influence of Cognitive Decline on Quality of Life After Coronary Bypass
Enrolling by invitation NCT03999398 - Short and Long-term Results of PCI in no Touch Vein-graft.
Recruiting NCT05414331 - WithDRawal Impact Of Postoperative Beta-Blocker N/A
Completed NCT02981680 - Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery N/A
Completed NCT00600704 - Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery N/A
Completed NCT06013605 - Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft N/A
Active, not recruiting NCT02731794 - On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist Phase 4
Completed NCT02722213 - Mindfulness & Stress Management Study for Cardiac Patients N/A
Completed NCT01285271 - A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon Phase 3
Completed NCT00823082 - Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass Phase 2