Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation
Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation
1 other identifier
observational
118
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 10, 2007
CompletedFirst Posted
Study publicly available on registry
December 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedApril 14, 2014
April 1, 2014
5.2 years
December 10, 2007
April 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation
six months and 1 year
Eligibility Criteria
Eligible subjects will be male or females age 18-85 that have elected to undergo or have undergone a minimally invasive "minimaze" surgery for the treatment of atrial firillation
You may qualify if:
- or older
- paroxysmal, persistent, or permanent atrial fibrillation
You may not qualify if:
- concomitant heart surgery requiring open thoracotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (3)
Han FT, Kasirajan V, Kowalski M, Kiser R, Wolfe L, Kalahasty G, Shepard RK, Wood MA, Ellenbogen KA. Results of a minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation: single-center experience with 12-month follow-up. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):370-7. doi: 10.1161/CIRCEP.109.854828. Epub 2009 Jun 2.
PMID: 19808492BACKGROUNDHan FT, Kasirajan V, Wood MA, Ellenbogen KA. Minimally invasive surgical atrial fibrillation ablation: patient selection and results. Heart Rhythm. 2009 Dec;6(12 Suppl):S71-6. doi: 10.1016/j.hrthm.2009.07.027. Epub 2009 Oct 24.
PMID: 19864190BACKGROUNDKasirajan V, Spradlin EA, Mormando TE, Medina AE, Ovadia P, Schwartzman DS, Gaines TE, Mumtaz MA, Downing SW, Ellenbogen KA. Minimally invasive surgery using bipolar radiofrequency energy is effective treatment for refractory atrial fibrillation. Ann Thorac Surg. 2012 May;93(5):1456-61. doi: 10.1016/j.athoracsur.2012.01.110.
PMID: 22541178RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth A Ellenbogen, MD
Virginia Commonwealth University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2007
First Posted
December 12, 2007
Study Start
March 1, 2007
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 14, 2014
Record last verified: 2014-04