Complex Arrhythmia Registry

NCT07024927 | Not Yet Recruiting DMC

• 1 other identifier: KS2025105
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF); Ventricular Tachycardia (VT)

Keywords

atrial fibrillation; ventricular tachycardia; ablation; registry study

Outcome Measures

Primary Outcomes (2)

• Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure

  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.

  12 months

Study Arms (3)

PAF

Paroxysmal atrial fibrillation

Procedure: AF ablation

PeAF

Persistent atrial fibrillation

Procedure: AF ablation

VT

Ventricular tachycardia

Procedure: VT ablation

Interventions

AF ablation 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.

PAF; PeAF

VT ablation 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.

VT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Deyong Long

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deyong Long, MD

CONTACT

+86 (010) 84005361; dragon2008@vip.sina.com

Deyong Long

CONTACT

+86 (010) 84005361; dragon2008@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)