Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: PVI + Lines ablation; Procedure: PVI; Procedure: PVI + CFE ablation

• Registration Number: NCT01203748
• Lead Sponsor: Abbott Medical Devices

Brief Summary

This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Study Start: 2010-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 589

Inclusion Criteria

• Patients age is18 years or greater;
• Patients undergoing a first-time ablation procedure for AF;
• Patients with persistent AF;
• Persistent AF will be defined as a sustained episode lasting > 7 days and less than 3 years.
• Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
• At least one episode of persistent AF must have been documented by ECG, holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation;
• Patients must be able and willing to provide written informed consent to participate in this investigation; and
• Patients must be willing and able to comply with all peri-ablation and follow-up requirements.

Exclusion Criteria

• Patients with paroxysmal AF;
• Patients with long-standing persistent AF;
• Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
• Patients with AF felt to be secondary to an obvious reversible cause;
• Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
• Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view); and
• Patients who are pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI + Lines Ablation	PVI + Lines ablation	-
PVI Ablation	PVI	-
PVI + CFE	PVI + CFE ablation	-

Primary Outcome Measures

Name	Time	Method
Freedom from AF	18 months	Freedom from documented AF episodes \> 30 seconds at 18 months after one or two ablation procedure with/without antiarrhythmic medications (AAD).; In the CT.gov website and in our protocol, we have stated the above primary endpoint (PE). This was the identical PE used in the original STAR AF I study. The intent of this PE was to present the success rates after both 1 procedure and after 2 procedures separately as was done in the original STAR AF I study. However, this is not entirely clear from the way the PE is stated. It may appear that our PE is the success rate after 2 procedures ("1 or 2" may imply "2"). Since our sample size calculation for the STAR AF II study was based on a single procedure success rate, the single procedure success rate with/without AAD will be used as the PE. The success rate after 2 procedures will be provided as the 1st. secondary endpoint. This clarification is done prior to locking the database and prior to any data analysis.

Secondary Outcome Measures

Name	Time	Method
Freedom from atrial flutter and AT	18 months	Freedom from documented atrial flutter and atrial tachycardia episodes \> 30 seconds at 18 months after one and two procedures with/without antiarrhythmic medications
Freedom from symptomatic AF	18 months	Freedom from symptomatic AF episodes \> 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Relationship of acute termination of AF to long-term procedural outcome	18 months	Relationship of acute termination of AF to long-term procedural outcome
Percentage achievement of complete linear block in linear ablation arm	18 months	Percentage achievement of complete linear block in linear ablation arm
Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome	18 months	Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
Freedom from atrial arrhythmia	18 months	Freedom from documented atrial arrhythmia episodes \> 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Freedom from documented or not atrial arrhythmia	18 months	Freedom from any atrial arrhythmia (documented or not) episodes \> 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death	18 months	Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
Number of repeat procedures	18 months	Number of repeat procedures
Effect of each strategy on AF cycle length/regularity/termination	18 months	Effect of each strategy on AF cycle length/regularity/termination
Effect of complete linear block on procedural outcome in linear ablation arm	18 months	Effect of complete linear block on procedural outcome in linear ablation arm
Correlation of AF burden to symptoms and quality of life changes	18 Months	Correlation of AF burden to symptoms and quality of life changes
Improvement in AF burden by > 90% post ablation procedure	18 months	Improvement in AF burden by \> 90% post ablation procedure
Freedom from symptomatic atrial arrhythmia	18 months	Freedom from symptomatic atrial arrhythmia episodes \> 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Procedure duration and fluoroscopy time	18 months	Procedure duration and fluoroscopy time
Evaluation of cost utility	18 months	Evaluation of cost utility
Quality of life measurements (SF-36, EQ-5D and CCS SAF)	18 MONTHS	Quality of life measurements (SF-36, EQ-5D and CCS SAF) at baseline, 6, 12 and 18 months after one and/or two ablation procedures
Cut off of AF burden that affects the Quality of Life measurement	18 months	Cut off of AF burden that affects the Quality of Life measurement

Trial Locations

Locations (2)

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada

St. Andrews War Memorial Hospital; 🇦🇺 Brisbane, Queensland, Australia