Complex Arrhythmia Registry

ConditionsAtrial Fibrillation (AF)Ventricular Tachycardia (VT)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

AF ablation
Procedure/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 ablation
Procedure/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.

Treatment groups

4,000 Participants

are divided into 3 treatment groups

Group A: PAF1 intervention

Group B: PeAF1 intervention

Group C: VT1 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov

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