PerAF: AF Termination vs Prespecified Ablation

NCT06837441 | Completed DMC

• 1 other identifier: TPAF
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The design of this study is an intervention, randomized, controlled study and contains two randomized groups：（1）AF-termination group；（2）Prespecified-ablation group.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat

  12 months

Secondary Outcomes (5)

• Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months；

  12 months

• Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months

  12 months

• Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months

  12 months

• Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure

  12 months

• Incidence of periprocedural adverse events.

  12 months

Study Arms (2)

AF-termination group

EXPERIMENTAL

Procedure: Atrial Fibrillation Termination

Prespecified-ablation group

SHAM COMPARATOR

Procedure: Prespecified Ablation

Interventions

Atrial Fibrillation Termination PROCEDURE

Pursuing Atrial Fibrillation Termination as a Procedural Endpoint

AF-termination group

Prespecified Ablation PROCEDURE

Prespecified Ablation Strategy Followed by Cardioversion

Prespecified-ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 and 80 years old;
• Patients undergoing a first-time ablation procedure for PersAF, and in spontaneous AF at the beginning of the procedure;
• Diagnosed as persistent AF according to the latest clinical guidelines，with atrial fibrillation lasting for at least one month;
• Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment;
• Patients must be able and willing to provide written informed consent to participate in this study;
• Patients must be willing and able to comply with all study follow- up requirements.

You may not qualify if:

• Uncontrolled congestive heart failure, EF \<35%;
• History of severe valve disease and/or prosthetic valve replacement;
• Myocardial infarction or stroke within 6 months;
• Severe congenital heart disease;
• Left atrial diameter ≥60mm;
• Contrast agent allergy;
• The use of anticoagulant drugs is contraindicated;
• Severe lung disease;
• Left atrial thrombus confirmed by preoperative esophageal ultrasound;
• Contraindications for cardiac catheterization;
• Prior left atrial ablation (surgical or catheter);
• Have performed any cardiac surgery within 2 months;
• Poor general health;
• Life expectancy \< 12 months, including factors such as physical inability to tolerate ablation or unstable disease conditions.-

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• The Shanghai Yangpu Central Hospital: collaborator
• Jinshan Hospital Affiliated to Fudan University: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Liu

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: February 20, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)