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Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03163836
Enrollment
500
Registered
2017-05-23
Start date
2006-04-01
Completion date
2023-03-10
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Valvular Heart Disease

Keywords

Double Valve Replacement, Atrial Fibrillation Ablation

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.

Interventions

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.

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

Sponsors

Guangzhou General Hospital of Guangzhou Military Command
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mortalityfrom the date of the surgery until the date of death, assess up to 120 monthsmortality from any cause
sinus rhythm ratefrom 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthssinus rhythm rate examined by 24h holter monitoring
strokefrom the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthsperioperative stroke
third degree heart block requiring permanent pacemaker implantationfrom the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthsthird degree heart block diagnosed via ECG

Secondary

MeasureTime frameDescription
warfarin requirementfrom 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthsoral warfarin requirement over 6 moths after the surgery
perioperative morbiditiesfrom the date of surgery until the date of first documented progression or date of death from any cause, assess up to 30 daysRedo for bleeding; Low cardiac output syndrome; Renal failure requiring dialysis; Pneumonia;
left atrium diameterfrom 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthsleft atrium diameter measured by transthoracic echocardiography
left ventricular ejection fractionfrom 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthsleft ventricular ejection fraction measured by transthoracic echocardiography
Warfarin-related bleedingfrom 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthsbleeding events occurred during the period when warfarin was used
Thromboembolic eventsfrom 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthsthromboembolic events
New York Heart Function classificationfrom 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 monthsNew York Heart Function classification

Countries

China

Contacts

Primary ContactWeida Zhang, MD
weidazhang1958@gmail.com86-020-88654578
Backup ContactGuang Tong, MD,PhD
guangrabbittong@gmail.com86-020-88654574

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026