Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 589
- Locations
- 2
- Primary Endpoint
- Freedom from AF
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
PVI + CFE
Intervention: PVI + CFE ablation (Procedure)
PVI + Lines Ablation
Intervention: PVI + Lines ablation (Procedure)
PVI Ablation
Intervention: PVI (Procedure)
Outcomes
Primary Outcomes
Freedom from AF
Time Frame: 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 Outcomes
- Percentage achievement of complete linear block in linear ablation arm(18 months)
- Freedom from atrial flutter and AT(18 months)
- Freedom from symptomatic AF(18 months)
- Relationship of acute termination of AF to long-term procedural outcome(18 months)
- Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome(18 months)
- Freedom from atrial arrhythmia(18 months)
- Freedom from documented or not atrial arrhythmia(18 months)
- Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death(18 months)
- Number of repeat procedures(18 months)
- Effect of each strategy on AF cycle length/regularity/termination(18 months)
- Effect of complete linear block on procedural outcome in linear ablation arm(18 months)
- Correlation of AF burden to symptoms and quality of life changes(18 Months)
- Improvement in AF burden by > 90% post ablation procedure(18 months)
- Freedom from symptomatic atrial arrhythmia(18 months)
- Procedure duration and fluoroscopy time(18 months)
- Evaluation of cost utility(18 months)
- Quality of life measurements (SF-36, EQ-5D and CCS SAF)(18 MONTHS)
- Cut off of AF burden that affects the Quality of Life measurement(18 months)