Placement of Permanent Pacemaker Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Weill Medical College of Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00512161
First received: August 3, 2007
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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

Condition
Cardiac Surgical Procedures

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Study to Determine the Frequency of Indications That Lead to the Placement of Permanent Pacemakers After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Enrollment: 500
Study Start Date: June 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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. Through investigation into the co-morbidities, diagnoses, or histories associated with an endpoint permanent pacemaker placement, it is possible that we will garner a better idea of who will require PPP.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiopulmonary Bypass Patients without a pacemaker already in place

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who have permanent pacemakers in place.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512161

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10026
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Gregory E. Kerr, M.D., M.B.A. Weill Medical College of Cornell University
Study Chair: John J. Savarese, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00512161     History of Changes
Other Study ID Numbers: 0701008942
Study First Received: August 3, 2007
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Any patient undergoing elective cardiac surgery

ClinicalTrials.gov processed this record on July 23, 2014