Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

NCT03163836 | Unknown

• 1 other identifier: RS2016003
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Current European Society of Cardiology Guidelines recommend concomitant atrial fibrillation (AF) ablation for all symptomatic patients undergoing other cardiac surgeries, but the safety and potential benefits of concomitant atrial fibrillation (AF) ablation at the time of double valve replacement remains unexamined. A retrospective review of patients with AF who underwent double valve replacement with or without concomitant surgical ablation in our institute starting from April 2006.

Conditions

Atrial Fibrillation; Valvular Heart Disease

Keywords

Double Valve Replacement; Atrial Fibrillation Ablation

Outcome Measures

Primary Outcomes (4)

• mortality

  mortality from any cause

  from the date of the surgery until the date of death, assess up to 120 months

• sinus rhythm rate

  sinus rhythm rate examined by 24h holter monitoring

  from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months

• stroke

  perioperative stroke

  from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 months

• third degree heart block requiring permanent pacemaker implantation

  third degree heart block diagnosed via ECG

  from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 months

Secondary Outcomes (7)

• perioperative morbidities

  from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 30 days

• Warfarin-related bleeding

  from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months

• Thromboembolic events

  from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months

• New York Heart Function classification

  from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months

• warfarin requirement

  from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months

Study Arms (2)

double valve replacement group

Patients received aortic+mitral valve replacement at Guangzhou General Hospital of Guangzhou Military Command with persistent or long-standing atrial fibrillation(AF) but did not received concomitant AF ablation. Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. Exclusion criteria for consideration for concomitant AF ablation includes \>70 years old, left atrium (LA) diameter \>7 cm, or preoperative left ventricle (LV) ejection fraction \< 40% and patients falls in these criteria were excluded from this group.

Procedure: double valve replacement

surgical ablation group

Patients received aortic+mitral valve replacement at Guangzhou General Hospital of Guangzhou Military Command with persistent or long-standing atrial fibrillation(AF) and received concomitant surgical ablation. Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months.

Procedure: double valve replacement; Procedure: surgical ablation

Interventions

double valve replacement PROCEDURE

After median sternotomy, cardiopulmonary bypass was established via bicaval and aortic cannulation. After cross-clamping of the aorta and cardioplegia, mitral and aortic replacement were performed. Supplementary procedures such tricuspid annuloplasty, ascending aorta replacement and coronary artery bypass grafting were performed as required. The left atrial appendage was excised to avoid thrombus formation.

Also known as: tricuspid annuloplasty, ascending aorta replacement, coronary artery bypass grafting

double valve replacement group; surgical ablation group

surgical ablation PROCEDURE

Both left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.

Also known as: tricuspid annuloplasty, ascending aorta replacement, coronary artery bypass grafting

surgical ablation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presented to our institute with valvular heart disease requiring double valve replacment and also present with persistent or long-standing persistent atrial fibrillation. Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months

You may qualify if:

• Patients presented to our institute with valvular heart disease requiring double valve replacement and also present with persistent or long-standing persistent atrial fibrillation.
• Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. First cardiac surgery, age\<70 years. left atrium diameter measured by transthoracic echocardiography\<7cm. Left ventricular ejection fraction \> 40%

You may not qualify if:

• \>70 years old, with LA diameter \>7 cm, or with LV ejection fraction \< 40% , repeated cardiac surgery, concomitant tricuspid valve replacement

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Valve Diseases

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Weida Zhang, MD

  Guangzhou General Hospital of Guangzhou Military Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weida Zhang, MD

CONTACT

86-020-88654578; weidazhang1958@gmail.com

Guang Tong, MD,PhD

CONTACT

86-020-88654574; guangrabbittong@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Surgery

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: May 23, 2017
• Study Start: April 1, 2006
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

CN (1)