## Protocol Section
### Identification Module
**NCT ID:** NCT02047279

**Acronym:** ALARM-vs-AF

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 14-04-31491
#### Organization
**Class:** NETWORK
**Full Name:** Meshalkin Research Institute of Pathology of Circulation
### Status Module
#### Completion Date
**Date:** 2017-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-09-11

**Type:** ACTUAL

**Last Update Submit Date:** 2017-09-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-09

**Type:** ACTUAL

#### Start Date
**Date:** 2014-09

**Type:** ACTUAL

**Status Verified Date:** 2017-09

#### Study First Post Date
**Date:** 2014-01-28
**Type:** ESTIMATED
**Study First Submit Date:** 2014-01-24
**Study First Submit QC Date:** 2014-01-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** Meshalkin Research Institute of Pathology of Circulation

#### Responsible Party

**Investigator Affiliation:** Meshalkin Research Institute of Pathology of Circulation

**Investigator Full Name:** Alexander Bogachev-Prokophiev

**Investigator Title:** PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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?

### Conditions Module

**Conditions:**

- Atrial Fibrillation

**Keywords:**

- Atrial fibrillation

- Mitral valve

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: maze procedure

- Procedure: mitral valve surgery

**Label:** MVS + maze

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: maze procedure

- Procedure: mitral valve surgery

- Procedure: left atrial reduction

**Label:** MVS + maze + LA reduction

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MVS + maze

- MVS + maze + LA reduction

**Description:** 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.

**Name:** maze procedure

**Other Names:**

- surgical ablation

- radiofrequency ablation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- MVS + maze

- MVS + maze + LA reduction

**Description:** 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.

**Name:** mitral valve surgery

**Other Names:**

- mitral valve repair

- mitral velve replacement

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- MVS + maze + LA reduction

**Description:** 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.

**Name:** left atrial reduction

**Other Names:**

- left atrial volume reduction

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Freedom from atrial fibrillation

**Time Frame:** 12 months

#### Secondary Outcomes

**Measure:** Rate of significant adverse events

**Time Frame:** 12 months

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Novosibirsk

**Country:** Russian Federation

**Facility:** Novosibirsk State Research Institute of Circulation Pathology

**Zip:** 630055

#### Overall Officials

**Official 1:**

**Affiliation:** Meshalkin Research Institute of Pathology of Circulation

**Name:** Alexander V Bogachev-Prokophiev, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

### Misc Info Module

- Version Holder: 2024-05-24
