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
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Pulmonary Vein Isolation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: January 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
The treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.
Procedure: Pulmonary Vein Isolation
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.
No Intervention: 2
The control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00587899

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Thoralf M. Sundt, III, M.D. Professor of Surgery, Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Thoralf, M. Sundt, III, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587899     History of Changes
Other Study ID Numbers: 06-005543
Study First Received: December 22, 2007
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Atrial Fibrillation
AF
A fib
cardiac ablation
modified maze procedure

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014