NCT02047279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

January 24, 2014

Last Update Submit

September 7, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationMitral valve

Outcome Measures

Primary Outcomes (1)

  • Freedom from atrial fibrillation

    12 months

Secondary Outcomes (1)

  • Rate of significant adverse events

    12 months

Study Arms (2)

MVS + maze

ACTIVE COMPARATOR

Procedure: Maze procedure, mitral valve surgery The scheme of lesion pattern: "box" lesion + line to mitral valve + line from "box" to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases. For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed.

Procedure: maze procedureProcedure: mitral valve surgery

MVS + maze + LA reduction

EXPERIMENTAL

Procedure: maze procedure, mitral valve surgery, left atrial reduction The scheme of lesion pattern: "box" lesion + line to mitral valve + line from "box" to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases. For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed. The enlarged left atria are plicated (suture technique) between the left and right pulmonary vein down to the inferior end of left atrial incision on the half-moon shape.

Procedure: maze procedureProcedure: mitral valve surgeryProcedure: left atrial reduction

Interventions

maze procedurePROCEDURE

The scheme of lesion pattern: "box" lesion + line to mitral valve + line from "box" to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases.

Also known as: surgical ablation, radiofrequency ablation
MVS + mazeMVS + maze + LA reduction
mitral valve surgeryPROCEDURE

For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed.

Also known as: mitral valve repair, mitral velve replacement
MVS + mazeMVS + maze + LA reduction
left atrial reductionPROCEDURE

The enlarged left atria are plicated (suture technique) between the left and right pulmonary vein down to the inferior end of left atrial incision on the half-moon shape.

Also known as: left atrial volume reduction
MVS + maze + LA reduction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Maze ProcedureRadiofrequency AblationMitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeCardiac Surgical ProceduresCardiovascular Surgical ProceduresThoracic Surgical ProceduresRadiofrequency TherapyTherapeuticsCardiac Valve Annuloplasty

Study Officials

  • Alexander V Bogachev-Prokophiev, PhD

    Meshalkin Research Institute of Pathology of Circulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 28, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

RU(1)