Study Stopped
enrollment has been lower than anticipated due to growth in the minimally invasive mitral valve repair practice.
Prophylactic Pulmonary Vein Isolation Study
A Randomized, Single-blind Prophylactic Pulmonary Vein Isolation Procedure Utilizing Bipolar Radiofrequency Ablation in Patients Undergoing Mitral Valve Surgery
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Jan 2007
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 22, 2007
CompletedFirst Posted
Study publicly available on registry
January 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedApril 14, 2011
April 1, 2011
2.8 years
December 22, 2007
April 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluated by the number of patients free of taking antiarrhythmic medications and free of AF as determined by a 24-hour Holter recording.
12 months
Study Arms (2)
1
OTHERThe treatment group will undergo operation for mitral valve disease with an additional procedure called Pulmonary Vein Isolation.
2
NO INTERVENTIONThe control group of patients will undergo operation for mitral valve disease without the additional Pulmonary Vein Isolation
Interventions
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.
Eligibility Criteria
You may qualify if:
- Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thoralf M. Sundt, III, M.D.
Professor of Surgery, Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2007
First Posted
January 8, 2008
Study Start
January 1, 2007
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 14, 2011
Record last verified: 2011-04