Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

May 24, 2017 updated by: Weida Zhang, Guangzhou General Hospital of Guangzhou Military Command

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangzhou General Hospital of Guangzhou Military Command
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • coronary artery bypass grafting
  • tricuspid annuloplasty
  • ascending aorta 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
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.
Other Names:
  • coronary artery bypass grafting
  • tricuspid annuloplasty
  • ascending aorta replacement
Procedure: surgical ablation
Both left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.
Other Names:
  • coronary artery bypass grafting
  • tricuspid annuloplasty
  • ascending aorta replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: from the date of the surgery until the date of death, assess up to 120 months
mortality from any cause
from the date of the surgery until the date of death, assess up to 120 months
sinus rhythm rate
Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
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
Time Frame: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
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
Time Frame: 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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative morbidities
Time Frame: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 30 days
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
Warfarin-related bleeding
Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
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
Thromboembolic events
Time Frame: 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
Time Frame: 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
Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
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
left ventricular ejection fraction
Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
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
left atrium diameter
Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Investigators

  • Principal Investigator: Weida Zhang, MD, Guangzhou General Hospital of Guangzhou Military Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2006

Primary Completion (ANTICIPATED)

March 10, 2023

Study Completion (ANTICIPATED)

March 10, 2023

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS2016003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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