Back to resultsA Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Cathter Ablation, Endpoint
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AF-termination Group
Prespecified-ablation Group
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria: . Age 18-80 years old. . Patients undergoing a first-time ablation procedure for PersAF. . Diagnosed as persistent AF according to the latest clinical guidelines. . 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. Exclusion Criteria: . Uncontrolled congestive heart failure; . History of severe valve disease and/or prosthetic valve replacement; . Myocardial infarction or stroke within 6 months; . Severe congenital heart disease; . EF <35%; . 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.
Sites / Locations
- Mu Qin
- Shanghai Chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AF-termination Group
Prespecified-ablation Group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
procedural details
All patients' procedural details: including procedure time, mapping time, fluoroscopy time, ablation time.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05921734
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cathter Ablation, Endpoint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
544 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AF-termination Group
Arm Type
Experimental
Arm Title
Prespecified-ablation Group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
AF-termination Group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prespecified-ablation Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame: 12 months
Secondary Outcome Measure Information:
Title
freedom from AF/AT after a single procedure without AADs (excludes the blanking period)
Description
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
Time Frame: 12 months
Title
freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)
Description
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
Time Frame: 12 months
Title
any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment
Description
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
Time Frame: 12 months
Title
freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
Description
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
Time Frame: 12 months
Title
procedural details
Description
All patients' procedural details: including procedure time, mapping time, fluoroscopy time, ablation time.
Time Frame
Time Frame: 12 months
Title
incidence of periprocedural adverse events
Description
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
Time Frame: 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. Age 18-80 years old.
. Patients undergoing a first-time ablation procedure for PersAF.
. Diagnosed as persistent AF according to the latest clinical guidelines.
. 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.
Exclusion Criteria:
. Uncontrolled congestive heart failure;
. History of severe valve disease and/or prosthetic valve replacement;
. Myocardial infarction or stroke within 6 months;
. Severe congenital heart disease;
. EF <35%;
. 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.
Facility Information:
Facility Name
Mu Qin
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation
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