Clinical trial NCT03163836: Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement
Official title: Impact of Concomitant Surgical Atrial Fibrillation Ablation in Patients Undergoing Double Valve Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Valvular Heart Disease
Keywords: Double Valve Replacement
Atrial Fibrillation Ablation
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: mortality
timeFrame: from the date of the surgery until the date of death, assess up to 120 months
measure: sinus rhythm rate
timeFrame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
measure: stroke
timeFrame: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
measure: third degree heart block requiring permanent pacemaker implantation
timeFrame: 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:
measure: perioperative morbidities
timeFrame: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 30 days
measure: Warfarin-related bleeding
timeFrame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
measure: Thromboembolic events
timeFrame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
measure: New York Heart Function classification
timeFrame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
measure: warfarin requirement
timeFrame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
measure: left ventricular ejection fraction
timeFrame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
measure: left atrium diameter
timeFrame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou General Hospital of Guangzhou Military Command
state: Guangdong
Study officials:
affiliation: Guangzhou General Hospital of Guangzhou Military Command
name: Weida Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: