A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05921734
• Other study ID #: CAPT-AF
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 544
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• AF-termination Group
Each center completes the ablation according to the above ablation procedure. The choice of ablation strategy is not restricted, but efforts should be made to achieve termination of AF during the ablation procedure. If cannot terminate AF for safety or other reasons involving difficulties to remap AFEGM or creating a complete conduction block despite the operator's best efforts, then direct current conversion (DCCV) was performed.
• Prespecified-ablation Group
Each center completes the prespecified ablation according to the above ablation procedure. Although there is no restriction on the choice of ablation strategy, Ablation must be performed following the PVI plus strategy, which can be combined with one or more additional ablation procedures, but each ablation must achieve its own endpoints, such as bidirectional block of linear damage, posterior wall isolation, etc. After completing the preset ablation steps, DCCV will be performed. If AF is terminated after or during ablation, it is also considered the endpoint of ablation in this group, but the preset ablation steps must be completed.

Locations

Country	Name	City	State
China	Mu Qin	Shanghai
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All patients included in the study had no incidence of Atrial fibrillation (AF), atrial tachycardia (AT) or Atrial flutter (AFL) at 12 months after ablation, excluding the initial 3-month blank period	Time Frame: 12 months
Secondary	freedom from AF/AT after a single procedure without AADs (excludes the blanking period)	All patients included in the study had no incidence of AF/AT after a single procedure without AADs at 12 months after ablation excluding the initial 3-month blank period	Time Frame: 12 months
Secondary	freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)	All patients included in the study had no incidence of freedom from AF/AT after a single procedure with or without anti-arrhythmic medications at 12 months after ablation excluding the initial 3-month blank period	Time Frame: 12 months
Secondary	any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment	All patients included in the study had no incidence of any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment at 12 months after ablation, excluding the initial 3-month blank period	Time Frame: 12 months
Secondary	freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure	All patients included in the study had no incidence of any AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment at 12 months after ablation, excluding the initial 3-month blank period	Time Frame: 12 months
Secondary	procedural details	All patients' procedural details: including procedure time, mapping time, fluoroscopy time, ablation time.	Time Frame: 12 months
Secondary	incidence of periprocedural adverse events	All patients' periprocedural adverse events including:ascular- significant groin,haematoma, pseudoaneurysm, AV fistula,Cardiac perforation,Pericardial effusion/ tamponade,Pericarditis,Pneumothorax/ haemothorax,Phrenic nerve injury,Periprocedural cerebrovascular accident - including air embolism,Esophageal injury - perforation / atrio-esophageal fistula,Pulmonary vein stenosis,Major bleeding event -including retroperitoneal bleeding,Heart block,Death	Time Frame: 12 months