Clinical trial NCT05921734: A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation
Official title: A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint Versus Prespecified Ablation Strategy Followed by Cardioversion in Patients With Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Cathter Ablation
Endpoint
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).


Eligibility criteria: Inclusion Criteria:

1. . Age 18-80 years old.
2. . Patients undergoing a first-time ablation procedure for PersAF.
3. . Diagnosed as persistent AF according to the latest clinical guidelines.
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.

Exclusion Criteria:

1. . Uncontrolled congestive heart failure;
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. . EF \<35%;
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.

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
timeFrame: Time Frame: 12 months
Secondary outcomes:
measure: freedom from AF/AT after a single procedure without AADs (excludes the blanking period)
timeFrame: Time Frame: 12 months
measure: freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)
timeFrame: Time Frame: 12 months
measure: any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment
timeFrame: Time Frame: 12 months
measure: freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
timeFrame: Time Frame: 12 months
measure: procedural details
timeFrame: Time Frame: 12 months
measure: incidence of periprocedural adverse events
timeFrame: Time Frame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Mu Qin
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: