NCT00512161

Brief Summary

The purpose of this study is to determine the predictors for placement of permanent pacemakers soon after cardiac surgery. We will measure the following to see what influence, if any, they have on predicting the need for permanent pacemaker implantation.

  1. 1.Type of cardiac surgery
  2. 2.Gender of patient
  3. 3.Patient's age
  4. 4.Preoperative heart rhythm and rate
  5. 5.Duration on cardiopulmonary bypass
  6. 6.Immediate post cardiopulmonary bypass heart rhythm and rate.
  7. 7.All heart rhythms and rates identified in the postoperative period prior to permanent pacemaker implantation.
  8. 8.Underlying heart rhythm and rates when permanent pacemaker is placed.
  9. 9.Ejection fraction before surgery
  10. 10.Ejection fraction immediately post-cardiopulmonary bypass

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

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

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

4.5 years

First QC Date

August 3, 2007

Last Update Submit

January 17, 2017

Conditions

Cardiac Surgical Procedures

Keywords

Any patient undergoing elective cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiopulmonary Bypass Patients without a pacemaker already in place

You may qualify if:

  • All patients between the ages of 18-99 years.
  • All patients undergoing cardiac surgery requiring cardiopulmonary bypass.

You may not qualify if:

  • Patients who have permanent pacemakers in place.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10026, United States

Location

Study Officials

  • Gregory E. Kerr, M.D., M.B.A.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • John J. Savarese, M.D.

    Weill Medical College of Cornell University

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 7, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)