Cardiac Surgical ProceduresNCT00512161
Placement of Permanent Pacemaker Study
An observational study of Cardiac Surgical Procedures, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Type of cardiac surgery 2. Gender of patient 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiopulmonary Bypass Patients without a pacemaker already in place
Who may be able to join
- All patients between the ages of 18-99 years.
- All patients undergoing cardiac surgery requiring cardiopulmonary bypass.
Who cannot join
- Patients who have permanent pacemakers in place.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10026
About this study
Official title: 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.
- Type of cardiac surgery
- Gender of patient
- Patient's age
- Preoperative heart rhythm and rate
- Duration on cardiopulmonary bypass
- Immediate post cardiopulmonary bypass heart rhythm and rate.
- All heart rhythms and rates identified in the postoperative period prior to permanent pacemaker implantation.
- Underlying heart rhythm and rates when permanent pacemaker is placed.
- Ejection fraction before surgery
- Ejection fraction immediately post-cardiopulmonary bypass
Read the 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.
- Conditions
- Cardiac Surgical Procedures
- Keywords
- Any patient undergoing elective cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory E. Kerr, M.D., M.B.A., Principal investigator, Weill Medical College of Cornell UniversityJohn J. Savarese, M.D., Study chair, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512161
- Sponsor's protocol ID
- 0701008942
- Status last verified
- Jan 2017
- First submitted
- 3 Aug 2007
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Determine the Frequency of Indications That Lead to the Placement of Permanent Pacemakers After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00512161
- Acronym / sponsor ID
- 0701008942
- Conditions
- Cardiac Surgical Procedures
- Keywords
- Any patient undergoing elective cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Type of cardiac surgery
- Gender of patient
- Patient's age
- Preoperative heart rhythm and rate
- Duration on cardiopulmonary bypass
- Immediate post cardiopulmonary bypass heart rhythm and rate.
- All heart rhythms and rates identified in the postoperative period prior to permanent pacemaker implantation.
- Underlying heart rhythm and rates when permanent pacemaker is placed.
- Ejection fraction before surgery
- Ejection fraction immediately post-cardiopulmonary bypass
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 design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiopulmonary Bypass Patients without a pacemaker already in place
Key inclusion criteria (2 listed)
- All patients between the ages of 18-99 years.
- All patients undergoing cardiac surgery requiring cardiopulmonary bypass.
Key exclusion criteria (1 listed)
- Patients who have permanent pacemakers in place.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory E. Kerr, M.D., M.B.A. principal investigator
Weill Medical College of Cornell University
John J. Savarese, M.D. study chair
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedures, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.