Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Prospective Analysis of the Wolf Minimaze Procedure for Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571597
• Other study ID #: HM10695
• Status: Completed
• Phase: N/A
• First received: December 10, 2007
• Last updated: April 10, 2014
• Start date: March 2007
• Est. completion date: May 2012

Study information

• Verified date: April 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.

Description:

Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18 or older

• paroxysmal, persistent, or permanent atrial fibrillation

Exclusion Criteria:

• concomitant heart surgery requiring open thoracotomy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Division of Cardiology Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Han 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. Review. — View Citation

Kasirajan 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 Thor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation		six months and 1 year	No