Placement of Permanent Pacemaker Study

January 17, 2017 updated by: Weill Medical College of Cornell University

A Retrospective Study to Determine the Frequency of Indications That Lead to the Placement of Permanent Pacemakers After Cardiac Surgery

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10026
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiopulmonary Bypass Patients without a pacemaker already in place

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (Estimate)

August 7, 2007

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0701008942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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