Atrial FibrillationNCT03163836
Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement
An observational study of Atrial Fibrillation and Valvular Heart Disease, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation, Valvular Heart Disease
- What is being tested?
- double valve replacement and surgical ablation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2006to 10 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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%
Who cannot join
- >70 years old, with LA diameter >7 cm, or with LV ejection fraction < 40% , repeated cardiac surgery, concomitant tricuspid valve replacement
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510000
Weida Zhang, MD, 86-020-88654578, weidazhang1958@gmail.com
Guang Tong, MD,PhD, 86-020-88654574, guangrabbittong@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Valvular Heart Disease
- Being tested
- double valve replacement, surgical ablation
- Keywords
- Double Valve Replacement, Atrial Fibrillation Ablation
- Medical subject headings
- Atrial Fibrillation, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double valve replacementProcedure or surgery
Also called tricuspid annuloplasty, ascending aorta replacement, coronary artery bypass grafting
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 ablationProcedure or surgery
Also called tricuspid annuloplasty, ascending aorta replacement, coronary artery bypass grafting
Both left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: double valve replacement; Procedure: surgical ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality from any cause
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Redo for bleeding; Low cardiac output syndrome; Renal failure requiring dialysis; Pneumonia;
Measured: 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
bleeding events occurred during the period when warfarin was used
Measured: 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
thromboembolic events
Measured: 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
New York Heart Function classification
Measured: 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
oral warfarin requirement over 6 moths after the surgery
Measured: 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
left ventricular ejection fraction measured by transthoracic echocardiography
Measured: 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
left atrium diameter measured by transthoracic echocardiography
Measured: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Apr 2006
- Primary completion10 Mar 2023 (estimated)
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weida Zhang, Guangzhou General Hospital of Guangzhou Military Command
- Investigators
- Weida Zhang, MD, Principal investigator, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163836
- Sponsor's protocol ID
- RS2016003
- Status last verified
- May 2017
- First submitted
- 3 Apr 2017
- Last updated
- 30 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Concomitant Surgical Atrial Fibrillation Ablation in Patients Undergoing Double Valve Replacement
- ClinicalTrials.gov ID
- NCT03163836
- Acronym / sponsor ID
- RS2016003
- Conditions
- Atrial Fibrillation, Valvular Heart Disease
- Keywords
- Double Valve Replacement, Atrial Fibrillation Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 10 Mar 2023 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double valve replacement group | – | Procedure: double valve replacementPatients 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. |
| surgical ablation group | – | Procedure: double valve replacement, Procedure: surgical ablationPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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%
Key exclusion criteria (1 listed)
- >70 years old, with LA diameter >7 cm, or with LV ejection fraction < 40% , repeated cardiac surgery, concomitant tricuspid valve replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| double valve replacementAlso: tricuspid annuloplasty, ascending aorta replacement, coronary artery bypass graftingAfter 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. | Procedure or surgery | double valve replacement group, surgical ablation group |
| surgical ablationAlso: tricuspid annuloplasty, ascending aorta replacement, coronary artery bypass graftingBoth left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp. | Procedure or surgery | surgical ablation group |
Primary outcome
mortality
Time frame: from the date of the surgery until the date of death, assess up to 120 months
mortality from any cause
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
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
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
7 secondary outcomes
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
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
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
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
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
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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weida Zhang, MD principal investigator
Guangzhou General Hospital of Guangzhou Military Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Valvular Heart Disease, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weida Zhang, MD (86-020-88654578, weidazhang1958@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: from the date of the surgery until the date of death, assess up to 120 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.