Prophylactic Pulmonary Vein Isolation Study

This study has been terminated.

(enrollment has been lower than anticipated due to growth in the minimally invasive mitral valve repair practice.)

Sponsor:

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00587899

First received: December 22, 2007

Last updated: April 12, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 22, 2007

Last Updated Date

April 12, 2011

Start Date ^ICMJE

January 2007

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00587899 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prophylactic Pulmonary Vein Isolation Study

Official Title ^ICMJE

A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery

Brief Summary

This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.

Detailed Description

Patients with a dilated left atrium (left upper chamber of the heart) that undergo mitral valve surgery may be at risk for the development of atrial fibrillation after surgery.

Atrial fibrillation (also known as "A-Fib" or AF) is an abnormal heart rhythm which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath. AF patients are at a higher risk of developing a stroke.

Participants who sign informed consent will be randomized into one of two groups by chance (as in the flip of a coin).

Approximately 77 patients will undergo their mitral valve operation along with Pulmonary Vein Isolation (a treatment group) and 77 patients who do not undergo Pulmonary Vein Isolation at the time of their mitral valve surgery (a control group).

The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation using a device that delivers radiofrequency energy to the heart muscle in order to create scar tissue to block electrical impulses that can trigger episodes of AF.

The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Procedure: Pulmonary Vein Isolation

Study Arm (s)

1
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.

Intervention: Procedure: Pulmonary Vein Isolation
No Intervention: 2
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium

Exclusion Criteria:

History of Atrial Fibrillation
Need for emergent cardiac surgery
Previous cardiac surgery
Preoperative need for an intraaortic balloon pump or intravenous inotropes
Current diagnosis of active endocarditis
Mental impairment/or experience other conditions which may not allow subject to understand nature
Significance and scope of study
Pregnancy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00587899

Other Study ID Numbers ^ICMJE

06-005543

Has Data Monitoring Committee

Responsible Party

Thoralf, M. Sundt, III, Principal Investigator, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thoralf M. Sundt, III, M.D.

Professor of Surgery, Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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