Atrial Fibrillation (AF)CARNCT07024927
Complex Arrhythmia Registry
An observational study of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT), run by Beijing Anzhen Hospital at 2 sites in China.
Trial summary
This is a prospective, non-randomized, multicenter observational registry study designed to systematically evaluate the long-term efficacy and safety of catheter ablation for treating atrial fibrillation (AF) and ventricular tachycardia (VT) in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Ventricular Tachycardia (VT)
- What is being tested?
- AF ablation and VT ablation
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 2 sitesChina
- Study dates
- 21 Oct 2025to Jun 2032
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 4,000 patients who first undergo ablation will be included and divided into three cohorts: 1,000 in the PAF cohort, 2,000 in the PeAF cohort, and 1,000 in the organic VT cohort.
- Atrial Fibrillation (AF) Cohort:
- Inclusion Criteria (Patients must meet ALL of the following criteria):
- Age ≥ 18 years.
- Diagnosed with atrial fibrillation (AF), including paroxysmal AF (PAF) and persistent AF (PsAF).
- Scheduled to undergo first-time catheter ablation for AF.
- Procedure to be performed using a 3D mapping system.
- Provision of signed written informed consent for study participation and willingness and ability to comply with all protocol-required follow-up assessments.
- Exclusion Criteria (Patients meeting ANY of the following criteria will be excluded):
- Severe congenital heart disease (e.g., Tetralogy of Fallot, corrected transposition of the great arteries).
- AF secondary to a clearly reversible cause (e.g., hyperthyroidism, post-operative state, acute alcohol intoxication).
- Unstable angina pectoris or acute myocardial infarction (MI) within 30 days prior to enrollment/procedure.
- Severe active infection (e.g., septic shock, sepsis).
- Contraindications to anticoagulation therapy.
- Current participation in another interventional clinical trial that may confound the results of this study.
- Any other condition where, in the investigator's judgment, the patient is unsuitable for participation in this study.
- Ventricular Tachycardia (VT) Cohort
- Inclusion Criteria (Patients must meet ALL of the following criteria):
- Age ≥ 18 years.
- Diagnosed with ventricular tachycardia (VT) associated with underlying structural heart disease, including:
- Ischemic heart disease (e.g., prior MI, coronary artery disease).
- Non-ischemic cardiomyopathy (e.g., dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy (HCM)).
- Scheduled to undergo first-time catheter ablation for VT.
- Procedure to be performed using a 3D mapping system.
- Provision of signed written informed consent for study participation and willingness and ability to comply with all protocol-required follow-up assessments.
- Exclusion Criteria (Patients meeting ANY of the following criteria will be excluded):
- VT due to a transient or reversible cause (e.g., acute myocardial ischemia, severe electrolyte imbalance).
- Idiopathic ventricular tachycardia (VT occurring in the absence of structural heart disease).
- Cardiac surgery within 60 days prior to the planned ablation procedure.
- Severe coagulopathy (e.g., platelet count < 50 x 10⁹/L, disseminated intravascular coagulation (DIC)).
- Severe heart failure with left ventricular ejection fraction (LVEF) < 20%.
- Severe active infection (e.g., septic shock, sepsis).
- Current participation in another interventional clinical trial that may confound the results of this study.
- Any other condition where, in the investigator's judgment, the patient is unsuitable for participation in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
No. 2 Anzhen Rd, Chaoyang District, 100029
Beijing, Beijing Municipality, 100029
- Not yet recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Jing Lin, 86+18610650190, 15332331992@163.com
About this study
Official title: Complex Arrhythmia Registry（CAR）： Long-term Outcomes of Catheter Ablation for Atrial Fibrillation or Ventricular Tachycardia： A Multicenter， Prospective Cohort Study
This is a prospective, non-randomized, multicenter observational registry study designed to systematically evaluate the long-term efficacy and safety of catheter ablation for treating atrial fibrillation (AF) and ventricular tachycardia (VT) in Chinese patients.
Read the detailed description
With the advancement of cardiac electrophysiology, the latest radiofrequency ablation technologies have played a significant role in the treatment of AF and VT. However, long-term outcome data on the application of these advanced techniques in Chinese patients still remains limited. The prospective, non-randomized, multicenter observational registry study will be divided into two cohorts:
- The AF Cohort will focus on evaluating the effectiveness and safety of different ablation workflows. It aims to redefine the relationship between AF recurrence and long-term outcomes using AF burden, thereby further optimizing treatment strategies for AF.
- The VT Cohort will primarily assess the application effects of novel technologies in VT treatment.
These data will provide critical reference information for future diagnostic and management strategies for complex arrhythmias.
- Being tested
- AF ablation, VT ablation
- Keywords
- atrial fibrillation, ventricular tachycardia, ablation, registry study
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF ablationProcedure or surgery
Catheter ablation will be performed under general anesthesia or local anesthesia. Pulmonary vein isolation (PVI) was performed in all patients. Beyond this mandatory step, the specific ablation strategy/protocol and ablation parameters/settings will be determined at the discretion of the operating physicians at each participating center.
VT ablationProcedure or surgery
For patients with hemodynamically stable VT, comprehensive chamber mapping (including activation mapping, substrate mapping, and entrainment mapping) is recommended. This aims to elucidate the VT activation sequence and identify the critical isthmus. Precise ablation targeting the isthmus should be performed to terminate the VT. For patients with hemodynamically unstable VT, substrate mapping during sinus rhythm can be performed first. This includes identification of low-voltage zones and abnormal electrograms (e.g., late potentials, local abnormal ventricular activities - LAVAs). Targeted substrate modification ablation should then be conducted based on the mapping findings. For all patients, complete substrate mapping is recommended after VT termination.
| Study group | Role | What they receive |
|---|---|---|
| PAF | Paroxysmal atrial fibrillation Receives: Procedure: AF ablation | |
| PeAF | Persistent atrial fibrillation Receives: Procedure: AF ablation | |
| VT | Ventricular tachycardia Receives: Procedure: VT ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure
Measured: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 12-month follow-up
Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia >30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 12-month follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start21 Oct 2025
- Primary completionJun 2032 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deyong Long, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024927
- Sponsor's protocol ID
- KS2025105
- Acronym
- CAR
- Status last verified
- Oct 2025
- First submitted
- 9 Jun 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Arrhythmia Registry（CAR）： Long-term Outcomes of Catheter Ablation for Atrial Fibrillation or Ventricular Tachycardia： A Multicenter， Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07024927
- Acronym / sponsor ID
- CAR / KS2025105
- Keywords
- atrial fibrillation, ventricular tachycardia, ablation, registry study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 17 Jun 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.
This is a prospective, non-randomized, multicenter observational registry study designed to systematically evaluate the long-term efficacy and safety of catheter ablation for treating atrial fibrillation (AF) and ventricular tachycardia (VT) in Chinese patients.
Detailed description
With the advancement of cardiac electrophysiology, the latest radiofrequency ablation technologies have played a significant role in the treatment of AF and VT. However, long-term outcome data on the application of these advanced techniques in Chinese patients still remains limited. The prospective, non-randomized, multicenter observational registry study will be divided into two cohorts:
- The AF Cohort will focus on evaluating the effectiveness and safety of different ablation workflows. It aims to redefine the relationship between AF recurrence and long-term outcomes using AF burden, thereby further optimizing treatment strategies for AF.
- The VT Cohort will primarily assess the application effects of novel technologies in VT treatment.
These data will provide critical reference information for future diagnostic and management strategies for complex arrhythmias.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAF | – | Procedure: AF ablationParoxysmal atrial fibrillation |
| PeAF | – | Procedure: AF ablationPersistent atrial fibrillation |
| VT | – | Procedure: VT ablationVentricular tachycardia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 4,000 patients who first undergo ablation will be included and divided into three cohorts: 1,000 in the PAF cohort, 2,000 in the PeAF cohort, and 1,000 in the organic VT cohort.
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 |
|---|---|---|
| AF ablationCatheter ablation will be performed under general anesthesia or local anesthesia. Pulmonary vein isolation (PVI) was performed in all patients. Beyond this mandatory step, the specific ablation strategy/protocol and ablation parameters/settings will be determined at the discretion of the operating physicians at each participating center. | Procedure or surgery | PAF, PeAF |
| VT ablationFor patients with hemodynamically stable VT, comprehensive chamber mapping (including activation mapping, substrate mapping, and entrainment mapping) is recommended. This aims to elucidate the VT activation sequence and identify the critical isthmus. Precise ablation targeting the isthmus should be performed to terminate the VT. For patients with hemodynamically unstable VT, substrate mapping during sinus rhythm can be performed first. This includes identification of low-voltage zones and abnormal electrograms (e.g., late potentials, local abnormal ventricular activities - LAVAs). Targeted substrate modification ablation should then be conducted based on the mapping findings. For all patients, complete substrate mapping is recommended after VT termination. | Procedure or surgery | VT |
Primary outcome
Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure
Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 12-month follow-up
Time frame: 12 months
Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia >30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 12-month follow-up.
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 4 Jun 2026.
- 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.
Deyong Long principal investigator
Beijing Anzhen Hospital
2 sites 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 (AF) and Ventricular Tachycardia (VT), run by Beijing Anzhen Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Deyong Long, MD (+86 (010) 84005361, dragon2008@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure (time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up). The study lists 2 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 4 Jun 2026.