Complex Arrhythmia Registry

NCT ID: NCT07024927

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2031-12-31

Brief 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.

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:

1. 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.

2. 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.

Conditions

Atrial Fibrillation (AF); Ventricular Tachycardia (VT)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PAF

Paroxysmal atrial fibrillation

AF ablation

Intervention Type: PROCEDURE

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.

PeAF

Persistent atrial fibrillation

AF ablation

Intervention Type: PROCEDURE

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

Ventricular tachycardia

VT ablation

Intervention Type: PROCEDURE

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.

Interventions

AF ablation

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.

Intervention Type: PROCEDURE

VT ablation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years.

2. Diagnosed with atrial fibrillation (AF), including paroxysmal AF (PAF) and persistent AF (PsAF).

3. Scheduled to undergo first-time catheter ablation for AF.

4. Procedure to be performed using a 3D mapping system.

5. Provision of signed written informed consent for study participation and willingness and ability to comply with all protocol-required follow-up assessments.

1. Age ≥ 18 years.

2. Diagnosed with ventricular tachycardia (VT) associated with underlying structural heart disease, including:

3. Ischemic heart disease (e.g., prior MI, coronary artery disease).

4. Non-ischemic cardiomyopathy (e.g., dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy (HCM)).

5. Scheduled to undergo first-time catheter ablation for VT.

6. Procedure to be performed using a 3D mapping system.

7. Provision of signed written informed consent for study participation and willingness and ability to comply with all protocol-required follow-up assessments.

Exclusion Criteria

1. Severe congenital heart disease (e.g., Tetralogy of Fallot, corrected transposition of the great arteries).

2. AF secondary to a clearly reversible cause (e.g., hyperthyroidism, post-operative state, acute alcohol intoxication).

3. Unstable angina pectoris or acute myocardial infarction (MI) within 30 days prior to enrollment/procedure.

4. Severe active infection (e.g., septic shock, sepsis).

5. Contraindications to anticoagulation therapy.

6. Current participation in another interventional clinical trial that may confound the results of this study.

7. Any other condition where, in the investigator's judgment, the patient is unsuitable for participation in this study.

2. Ventricular Tachycardia (VT) Cohort

1. VT due to a transient or reversible cause (e.g., acute myocardial ischemia, severe electrolyte imbalance).

2. Idiopathic ventricular tachycardia (VT occurring in the absence of structural heart disease).

3. Cardiac surgery within 60 days prior to the planned ablation procedure.

4. Severe coagulopathy (e.g., platelet count < 50 x 10⁹/L, disseminated intravascular coagulation (DIC)).

5. Severe heart failure with left ventricular ejection fraction (LVEF) < 20%.

6. Severe active infection (e.g., septic shock, sepsis).

7. Current participation in another interventional clinical trial that may confound the results of this study.

8. Any other condition where, in the investigator's judgment, the patient is unsuitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deyong Long

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Countries

China

Central Contacts

Deyong Long, MD

Role: CONTACT

dragon2008@vip.sina.com

+86 (010) 84005361

Deyong Long

Role: CONTACT

dragon2008@vip.sina.com

+86 (010) 84005361

Facility Contacts

Jing Lin

Role: primary

15332331992@163.com

86+18610650190

Other Identifiers

KS2025105

Identifier Type: -

Identifier Source: org_study_id