Clinical trial NCT01203748: Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Official title: Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from AF
timeFrame: 18 months
Secondary outcomes:
measure: Freedom from atrial arrhythmia
timeFrame: 18 months
measure: Freedom from atrial flutter and AT
timeFrame: 18 months
measure: Freedom from documented or not atrial arrhythmia
timeFrame: 18 months
measure: Freedom from symptomatic AF
timeFrame: 18 months
measure: Freedom from symptomatic atrial arrhythmia
timeFrame: 18 months
measure: Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
timeFrame: 18 months
measure: Procedure duration and fluoroscopy time
timeFrame: 18 months
measure: Number of repeat procedures
timeFrame: 18 months
measure: Effect of each strategy on AF cycle length/regularity/termination
timeFrame: 18 months
measure: Relationship of acute termination of AF to long-term procedural outcome
timeFrame: 18 months
measure: Percentage achievement of complete linear block in linear ablation arm
timeFrame: 18 months
measure: Effect of complete linear block on procedural outcome in linear ablation arm
timeFrame: 18 months
measure: Quality of life measurements (SF-36, EQ-5D and CCS SAF)
timeFrame: 18 MONTHS
measure: Correlation of AF burden to symptoms and quality of life changes
timeFrame: 18 Months
measure: Improvement in AF burden by > 90% post ablation procedure
timeFrame: 18 months
measure: Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
timeFrame: 18 months
measure: Cut off of AF burden that affects the Quality of Life measurement
timeFrame: 18 months
measure: Evaluation of cost utility
timeFrame: 18 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: St. Andrews War Memorial Hospital
state: Queensland
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
affiliation: Southlake Regional Health Centre
name: Atul Verma, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terricabras M, Mantovan R, Jiang CY, Betts TR, Chen J, Deisenhofer I, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P, Verma A; Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II) Investigators. Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2025473. doi: 10.1001/jamanetworkopen.2020.25473.
citation: Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
citation: Verma A, Sanders P, Macle L, Deisenhofer I, Morillo CA, Chen J, Jiang CY, Ernst S, Mantovan R. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II): design and rationale. Am Heart J. 2012 Jul;164(1):1-6.e6. doi: 10.1016/j.ahj.2012.04.002.