Clinical trial NCT02047279: Ablation and Left Atrium Reduction During Mitral Valve Surgery for Atrial Fibrillation
Official title: Left Atrium Reduction Versus no Left Atrium Reduction for Patients With Enlarged Left Atria and Persistent or Long Standing Persistent Atrial Fibrillation Undergoing Mitral Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Mitral valve
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2014-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate left atrial volume reduction surgery concomitant with the maze procedure and mitral valve repair/replacement in patients with atrial fibrillation with an enlarged left atria.

Detailed description: The Cox-Maze procedure has been a gold standard for the treatment of atrial fibrillation. Success of the modified maze procedure after valvular operation with an enlarged left atria and persistent and longstanding persistent atrial fibrillation remains suboptimal. The question addressed was: In adults undergoing a maze procedure for atrial fibrillation does left atrial size reduction compared to maze surgery alone improve maze surgery success?

Eligibility criteria: Inclusion Criteria:

* Able to sign Informed Consent and Release of Medical Information forms
* Age ≥ 18 years
* Clinical indications for mitral valve surgery for organic mitral valve disease Note: May include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. Surgical intervention may be performed via sternotomy or minimally invasive procedure.
* a) Persistent atrial fibrillation (AF) within 6 months prior to randomization, defined as non self-terminating AF lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.

Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.

b) Longstanding persistent AF is defined as continuous AF of greater than one year duration.

Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the OR.

* left atrial diameter \> 65mm
* Able to use heart rhythm monitor

Exclusion Criteria:

* AF is paroxysmal
* AF without indication for mitral valve surgery
* Concomitant coronary artery bypass grafting (CABG), aortic arch or aortic valve procedure
* Previous catheter ablation for AF
* Redo cardiac surgery
* Left ventricle ejection fraction (LV EF) \< 35%
* Life expectancy of less than one year
* Mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study

Primary outcomes:
measure: Freedom from atrial fibrillation
timeFrame: 12 months
Secondary outcomes:
measure: Rate of significant adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Research Institute of Circulation Pathology
Study officials:
affiliation: Meshalkin Research Institute of Pathology of Circulation
name: Alexander V Bogachev-Prokophiev, PhD
role: PRINCIPAL_INVESTIGATOR
References: