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Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement

Primary Purpose

Atrial Fibrillation, Rheumatic Heart Disease

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

surgical prevention of atrial fibrillation

cardiomonitor

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, radiofrequency ablation, prevention of AF, mitral valve, left atrium enlargement, cryoablation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

rheumatic mitral valve lesion
the absence a history of AF
sinus rhythm
left atrium size more than 6.0 cm

Exclusion Criteria:

refusal to participate in the study
aortic stenosis / regurgitation
coronary atherosclerosis

Sites / Locations

MeshalkinRI

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

without prevention

group of prevention

Arm Description

isolated mitral valve replacement or reconstruction, implantation of cardiac monitor

mitral valve replacement or reconstruction with surgical prevention of AF (concomitant ablation of the left atrium) and implantation of cardiac monitor. Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe.

Outcomes

Primary Outcome Measures

composite outcome measure of complications

Secondary Outcome Measures

number of participants with freedom from AF according to the long-term ECG monitoring

transport function of the left atrium according to TTE (transthoracic echo)

Full Information

NCT ID

NCT02474108

First Posted

April 23, 2015

Last Updated

September 8, 2017

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT02474108

Brief Title

Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement

Official Title

Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

March 2, 2015 (Actual)

Primary Completion Date

May 5, 2016 (Actual)

Study Completion Date

October 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement

Detailed Description

Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke. Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Rheumatic Heart Disease

Keywords

atrial fibrillation, radiofrequency ablation, prevention of AF, mitral valve, left atrium enlargement, cryoablation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

without prevention

Arm Type

Placebo Comparator

Arm Description

isolated mitral valve replacement or reconstruction, implantation of cardiac monitor

Arm Title

group of prevention

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

surgical prevention of atrial fibrillation

Intervention Description

Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium.

Intervention Type

Device

Intervention Name(s)

cardiomonitor

Intervention Description

in both groups cardiac rhythm will be controlled by a cardiomonitor

Primary Outcome Measure Information:

Title

composite outcome measure of complications

Time Frame

up to 1 year

Secondary Outcome Measure Information:

Title

number of participants with freedom from AF according to the long-term ECG monitoring

Time Frame

1 year

Title

transport function of the left atrium according to TTE (transthoracic echo)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: rheumatic mitral valve lesion the absence a history of AF sinus rhythm left atrium size more than 6.0 cm Exclusion Criteria: refusal to participate in the study aortic stenosis / regurgitation coronary atherosclerosis

Facility Information:

Facility Name

MeshalkinRI

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement

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