Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

Atrial Fibrillation Clinical Trial

Official title:

Impact of Concomitant Surgical Atrial Fibrillation Ablation in Patients Undergoing Double Valve Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03163836
• Other study ID #: RS2016003
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2017
• Last updated: May 24, 2017
• Start date: April 1, 2006
• Est. completion date: March 10, 2023

Study information

• Verified date: May 2017
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: Weida Zhang, MD
• Phone: 86-020-88654578
• Email: weidazhang1958[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. Concomitant surgical AF ablation was offered to suitable patients as determined by the surgeon, and patients then decided whether to undergo the additional procedure.

The operations were performed through median sternotomy and under cardiopulmonary bypass. The bipolar ablation clamp was positioned precisely around the pulmonary veins (PV) for bilateral circular ablation. After Marsh ligament cutting and cross-clamping the ascending aorta, the left atrial appendage was resected and left atrial cavity exposed through an incision behind the interatrial groove. Then, linear ablations were performed between the left and right inferior PVs, between the left and right superior PVs, between the left superior PV and the opening of the left atrial appendage, and between the line connecting bilateral inferior PVs and the mitral valve isthmus. Ablation at the right atrium was then performed. Briefly, the bipolar ablation clamp was positioned around the inferior vena cava (IVC) and right atrial appendage for circular ablation. An L-shaped incision was then made on the anterior wall of the right atrium and linear ablations were performed vertically from the incision to the interatrial groove and tricuspid annulus, to the ablation ring around the right atrial appendage, and from the superior vena cava to the ablation ring around the inferior vena cava.

The left atrial appendage was always excluded by resection and the incision was closed with continuous running stitches. Temporary pacemakers were placed in all patients and activated when heart rate was less than 70 beats per minute.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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%

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Procedure:
• double valve replacement
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.
• surgical ablation
Both left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.

Locations

Country	Name	City	State
China	Guangzhou General Hospital of Guangzhou Military Command	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	mortality from any cause	from the date of the surgery until the date of death, assess up to 120 months
Primary	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
Primary	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
Primary	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	perioperative morbidities	Redo for bleeding; Low cardiac output syndrome; Renal failure requiring dialysis; Pneumonia;	from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 30 days
Secondary	Warfarin-related bleeding	bleeding events occurred during the period when warfarin was used	from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
Secondary	Thromboembolic events	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
Secondary	New York Heart Function classification	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
Secondary	warfarin requirement	oral warfarin requirement over 6 moths after the surgery	from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
Secondary	left ventricular ejection fraction	left ventricular ejection fraction measured by transthoracic echocardiography	from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
Secondary	left atrium diameter	left atrium diameter measured by transthoracic echocardiography	from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months