NCT00417092

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

December 28, 2006

Last Update Submit

September 21, 2007

Conditions

Cardiac Pacing,ArtificialCoronary Artery BypassVentricular Function, Left

Keywords

coronary artery bypass graftingreduced left ventricular functionpostoperative pacingcardiac resynchronization

Outcome Measures

Primary Outcomes (1)

  • Duration of Intensive Care Treatment

Secondary Outcomes (9)

  • 30 day mortality

  • Major adverse events

  • Duration of Hospital Stay

  • Hemodynamic parameters

  • Inotrope use

  • +4 more secondary outcomes

Interventions

Postoperative PacingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective or urgent coronary artery bypass grafting
  • Preoperative ejection fraction less than 40%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Schleswig Holstein, Campus Luebeck, Cardiac Surgery

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Study Officials

  • Uwe KH Wiegand, MD

    University Hospital Schlesig Holstein, Campus Luebeck, Medicine II, Luebeck, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2006

First Posted

December 29, 2006

Study Start

December 1, 2006

Study Completion

September 1, 2007

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations

DE(1)