Cardiovascular DiseasesNCT06984731
The Safety and Efficacy of Radiofrequency Ablation After Left Atrial Appendage Occlusion.
An observational study of Cardiovascular Diseases and Arrhythmia, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Objective: To evaluate the safety and efficacy of transcatheter atrial fibrillation ablation 1 month after WATCHMAN FLX left atrial appendage closure in patients with nonvalvular atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Arrhythmia
- What is being tested?
- left atrial appendage closure and radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with symptomatic persistent atrial fibrillation, defined as: inability to spontaneously transition to sinus rhythm, lasting for more than 7 days, resistance or intolerance to at least Class I, II, or III antiarrhythmic drugs.
Who may be able to join
- ≥18 years of age, diagnosed with nonvalvular atrial fibrillation;
- Meet the indications for receiving WATCHMAN FLX left atrial appendicular closure and transcatheter atrial fibrillation ablation;
- Preoperative imaging evaluation showed that the anatomical structure of the left atrial appendage was suitable for implantation with the WATCHMAN FLX device;
- The patient agrees to participate in the study and signs the informed consent.
Who cannot join
- valvular heart disease or other structural heart disease that causes atrial fibrillation;
- left auricular thrombus or acute thrombotic event was found before surgery;
- Patients with severe bleeding tendency or recent major bleeding events (such as massive gastrointestinal bleeding, cerebral hemorrhage, etc.);
- Patients who are unable to complete postoperative follow-up (such as life expectancy of less than 1 year or poor compliance);
- Other serious diseases (such as liver and kidney failure, active infection, etc.) were found in preoperative examination;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jian Zhang MD contact
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of Nantong University
Nantong, Jiangsu, 226001
Qi Lu MD, 13962989292, luqint@sina.com
About this study
Official title: Clinical Trial Protocol for Safety and Efficacy of Transcatheter Ablation After Left Atrial Appendicular Occlusion With WATCHMAN FLX
Objective: To evaluate the safety and efficacy of transcatheter atrial fibrillation ablation 1 month after WATCHMAN FLX left atrial appendage closure in patients with nonvalvular atrial fibrillation.
Read the detailed description
Atrial fibrillation (AF) is one of the most common persistent arrhythmias in the clinic, and its incidence increases significantly with age, posing a serious threat to public health worldwide. One of the most serious complications in patients with atrial fibrillation is thromboembolic events, especially cardiogenic stroke. Cardiogenic stroke caused by atrial fibrillation accounts for 20%-30% of all stroke cases, and the mortality and disability rates of patients after stroke are significantly increased. Studies have shown that about 90% of the thrombus in patients with NVAF comes from the left atrial appendage (LAA). Therefore, isolating the left atrial appendage from the atrium to prevent stroke has become an important strategy in the management of patients with atrial fibrillation. This surgical method is called left atrial appendage occlusion (LAAO).
Moreover, both international and national guidelines for arrhythmia management indicate that rhythm control and stroke prevention are equally important for patients with atrial fibrillation. Although left atrial ear closure is effective in reducing the risk of stroke associated with atrial fibrillation, it does not address arrhythmia in patients. For heart rhythm control, catheter ablation is one of the most effective treatments available. It has been proven to significantly improve sinus rhythm maintenance and quality of life in patients with atrial fibrillation in several randomized controlled trials (RCTS). These studies suggest that catheter ablation is the preferred method for rhythm control in patients with paroxysmal AF, with better long-term results than medical treatment.
To comprehensively solve the problem of rhythm control and stroke prevention in patients with atrial fibrillation, the combination of catheter ablation and left atrial ear closure is a feasible and promising treatment strategy. Catheter ablation is designed to restore sinus rhythm by interfering with the triggering mechanism of atrial fibrillation, while left atrial appendage closure reduces stroke risk by isolating the main site of thrombosis. The combination of the two surgical methods not only improves the rate of sinus rhythm maintenance in patients but also significantly reduces the risk of stroke and all-cause death.
At present, the combined application of these two surgeries is gradually increasing in clinical practice. Some studies and expert consensus suggest that combined treatment goals can be achieved through "one-stop surgery" (performing both catheter ablation and left atrial appendage closure in one procedure) or phased surgery (performing one procedure before the other). However, there is no consensus on the optimal surgical sequence. Some studies have shown that "one-stop" surgery may shorten the length of hospital stay, and reduce surgical risks and patients' economic burden in the same period [13]. A phased procedure allows doctors to better evaluate the results after the initial surgery and reduce the overall surgical risk for the patient.
In the consensus of atrial fibrillation management experts in China in 2021, Category Ⅱb recommendation for "one-stop surgery" was proposed, suggesting that for some patients with nonvalvular atrial fibrillation who have indications of both catheter ablation and left atrial artery occlusion, it is reasonable to perform left atrial artery occlusion at the same time of catheter ablation. Despite this, there is currently a lack of trials to verify the safety and effectiveness of different surgical sequences.
Therefore, the purpose of this study was to evaluate the safety and effectiveness of transcranial atrial fibrillation ablation with WATCHMAN FLX 1 month after left atrial appendicular closure, to provide evidence-based medical evidence for optimizing the comprehensive management of patients with atrial fibrillation, and to further explore the optimal combined application strategy of the two surgical methods in patients with nonvalvular atrial fibrillation.
- Conditions
- Cardiovascular Diseases, Arrhythmia
- Being tested
- left atrial appendage closure, radiofrequency ablation
- Keywords
- Atrial Fibrillation (AF), Left Atrial Appendage closure with WATCHMAN device, Radiofrequency ablation
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left atrial appendage closureProcedure or surgery
Also called left atrial appendage closure with WATCHMAN FLX
Patients with atrial fibrillation underwent transcatheter radiofrequency cardiac ablation 1 month after left atrial appendage closure with WATCHMAN FLX
radiofrequency ablationProcedure or surgery
Patients with atrial fibrillation underwent transcatheter radiofrequency cardiac ablation 1 month after left atrial appendage closure with WATCHMAN FLX
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients who meet the diagnosis of non-valvular atrial fibrillation and plan to receive sequential treatment of WATCHMAN FLX left atrial appendage occlusion and transcatheter atrial fibrillation ablation. Receives: Procedure: left atrial appendage closure; Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success at one year
The success rate of complete left atrial appendage closure within 12 months post-WATCHMAN FLX left atrial appendage occlusion surgery, as evaluated by contrast-enhanced computed tomography angiography (CTA) of the left atrial appendage.
Measured: one year
Secondary outcomes (5)
Rate of adverse events
The incidence of surgery-related complications and adverse events occurring within 30 days post-procedure following left atrial appendage occlusion and radiofrequency ablation was evaluated. This included the incidence of pericardial effusion, procedural access site complications, vascular complications, and infections.
The incidence of surgery-related complications and adverse events within 12 months post-procedure was assessed. This encompassed severe bleeding (defined as bleeding requiring blood transfusion or surgical intervention), pericardial tamponade, systemic embolism (including ischemic stroke and other embolic events), occluder-associated thrombosis (DRT), new or enlarged residual shunt (PDL, defined as >5mm), postoperative acute left heart failure, and rehospitalization.
Measured: one year
Arrhythmia recurrence during blanking period
The success rate of treatment within 3 months after radiofrequency ablation (early recurrence) : No recurrence of atrial arrhythmia ≥30 seconds;
Measured: one year
Arrhythmia recurrence after blanking period
The success rate of treatment within 12 months after radiofrequency ablation (late recurrence) : There is no recurrence of atrial arrhythmia ≥30 seconds or more during the 4-12 months after the operation.
Measured: one year
Incidence of stroke
Incidence of stroke within 12 months after left atrial appendage occlusion: No stroke occurred.
Measured: one year
Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT)
The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT) with the values ranging from 20 - 140 (higher scores mean a worse outcome)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start21 Apr 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984731
- Sponsor's protocol ID
- 2025-K080-01
- Status last verified
- Feb 2025
- First submitted
- 22 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol for Safety and Efficacy of Transcatheter Ablation After Left Atrial Appendicular Occlusion With WATCHMAN FLX
- ClinicalTrials.gov ID
- NCT06984731
- Acronym / sponsor ID
- 2025-K080-01
- Conditions
- Cardiovascular Diseases, Arrhythmia
- Keywords
- Atrial Fibrillation (AF), Left Atrial Appendage closure with WATCHMAN device, Radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 22 May 2025 (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.
Objective: To evaluate the safety and efficacy of transcatheter atrial fibrillation ablation 1 month after WATCHMAN FLX left atrial appendage closure in patients with nonvalvular atrial fibrillation.
Detailed description
Atrial fibrillation (AF) is one of the most common persistent arrhythmias in the clinic, and its incidence increases significantly with age, posing a serious threat to public health worldwide. One of the most serious complications in patients with atrial fibrillation is thromboembolic events, especially cardiogenic stroke. Cardiogenic stroke caused by atrial fibrillation accounts for 20%-30% of all stroke cases, and the mortality and disability rates of patients after stroke are significantly increased. Studies have shown that about 90% of the thrombus in patients with NVAF comes from the left atrial appendage (LAA). Therefore, isolating the left atrial appendage from the atrium to prevent stroke has become an important strategy in the management of patients with atrial fibrillation. This surgical method is called left atrial appendage occlusion (LAAO).
Moreover, both international and national guidelines for arrhythmia management indicate that rhythm control and stroke prevention are equally important for patients with atrial fibrillation. Although left atrial ear closure is effective in reducing the risk of stroke associated with atrial fibrillation, it does not address arrhythmia in patients. For heart rhythm control, catheter ablation is one of the most effective treatments available. It has been proven to significantly improve sinus rhythm maintenance and quality of life in patients with atrial fibrillation in several randomized controlled trials (RCTS). These studies suggest that catheter ablation is the preferred method for rhythm control in patients with paroxysmal AF, with better long-term results than medical treatment.
To comprehensively solve the problem of rhythm control and stroke prevention in patients with atrial fibrillation, the combination of catheter ablation and left atrial ear closure is a feasible and promising treatment strategy. Catheter ablation is designed to restore sinus rhythm by interfering with the triggering mechanism of atrial fibrillation, while left atrial appendage closure reduces stroke risk by isolating the main site of thrombosis. The combination of the two surgical methods not only improves the rate of sinus rhythm maintenance in patients but also significantly reduces the risk of stroke and all-cause death.
At present, the combined application of these two surgeries is gradually increasing in clinical practice. Some studies and expert consensus suggest that combined treatment goals can be achieved through "one-stop surgery" (performing both catheter ablation and left atrial appendage closure in one procedure) or phased surgery (performing one procedure before the other). However, there is no consensus on the optimal surgical sequence. Some studies have shown that "one-stop" surgery may shorten the length of hospital stay, and reduce surgical risks and patients' economic burden in the same period [13]. A phased procedure allows doctors to better evaluate the results after the initial surgery and reduce the overall surgical risk for the patient.
In the consensus of atrial fibrillation management experts in China in 2021, Category Ⅱb recommendation for "one-stop surgery" was proposed, suggesting that for some patients with nonvalvular atrial fibrillation who have indications of both catheter ablation and left atrial artery occlusion, it is reasonable to perform left atrial artery occlusion at the same time of catheter ablation. Despite this, there is currently a lack of trials to verify the safety and effectiveness of different surgical sequences.
Therefore, the purpose of this study was to evaluate the safety and effectiveness of transcranial atrial fibrillation ablation with WATCHMAN FLX 1 month after left atrial appendicular closure, to provide evidence-based medical evidence for optimizing the comprehensive management of patients with atrial fibrillation, and to further explore the optimal combined application strategy of the two surgical methods in patients with nonvalvular atrial fibrillation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Procedure: left atrial appendage closure, Procedure: radiofrequency ablationPatients who meet the diagnosis of non-valvular atrial fibrillation and plan to receive sequential treatment of WATCHMAN FLX left atrial appendage occlusion and transcatheter atrial fibrillation ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with symptomatic persistent atrial fibrillation, defined as: inability to spontaneously transition to sinus rhythm, lasting for more than 7 days, resistance or intolerance to at least Class I, II, or III antiarrhythmic drugs.
Key inclusion criteria (4 listed)
- ≥18 years of age, diagnosed with nonvalvular atrial fibrillation;
- Meet the indications for receiving WATCHMAN FLX left atrial appendicular closure and transcatheter atrial fibrillation ablation;
- Preoperative imaging evaluation showed that the anatomical structure of the left atrial appendage was suitable for implantation with the WATCHMAN FLX device;
- The patient agrees to participate in the study and signs the informed consent.
Key exclusion criteria (6 listed)
- valvular heart disease or other structural heart disease that causes atrial fibrillation;
- left auricular thrombus or acute thrombotic event was found before surgery;
- Patients with severe bleeding tendency or recent major bleeding events (such as massive gastrointestinal bleeding, cerebral hemorrhage, etc.);
- Patients who are unable to complete postoperative follow-up (such as life expectancy of less than 1 year or poor compliance);
- Other serious diseases (such as liver and kidney failure, active infection, etc.) were found in preoperative examination;
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 |
|---|---|---|
| left atrial appendage closureAlso: left atrial appendage closure with WATCHMAN FLXPatients with atrial fibrillation underwent transcatheter radiofrequency cardiac ablation 1 month after left atrial appendage closure with WATCHMAN FLX | Procedure or surgery | Experimental group |
| radiofrequency ablationPatients with atrial fibrillation underwent transcatheter radiofrequency cardiac ablation 1 month after left atrial appendage closure with WATCHMAN FLX | Procedure or surgery | Experimental group |
Primary outcome
Treatment success at one year
Time frame: one year
The success rate of complete left atrial appendage closure within 12 months post-WATCHMAN FLX left atrial appendage occlusion surgery, as evaluated by contrast-enhanced computed tomography angiography (CTA) of the left atrial appendage.
5 secondary outcomes
Rate of adverse events
Time frame: one year
Arrhythmia recurrence during blanking period
Time frame: one year
Arrhythmia recurrence after blanking period
Time frame: one year
Incidence of stroke
Time frame: one year
Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT)
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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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.
Jian Zhang MD contact
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 Cardiovascular Diseases and Arrhythmia, run by Affiliated Hospital of Nantong University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Lu MD (+8613962989292, luqint@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success at one year (time frame: one year). 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 22 May 2025.