Clinical trial NCT06837441: PerAF: AF Termination vs Prespecified Ablation
Official title: Atrial Fibrillation Termination Versus Prespecified Ablation for Persistent Atrial Fibrillation:A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: The Shanghai Yangpu Central Hospital
name: Jinshan Hospital Affiliated to Fudan University
First posted: 2025-02-20
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months；
timeFrame: 12 months
measure: Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months
timeFrame: 12 months
measure: Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months
timeFrame: 12 months
measure: Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
timeFrame: 12 months
measure: Incidence of periprocedural adverse events.
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: