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

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: PVI; Procedure: PVI + Lines ablation; Procedure: PVI + CFE ablation

• Study Type: Interventional
• Enrollment (Actual): 589
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia
      • St. Andrews War Memorial Hospital
• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 8C3
      • Southlake Regional Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PVI + Lines Ablation	Procedure: PVI + Lines ablation; Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)
ACTIVE_COMPARATOR: PVI Ablation	Procedure: PVI; Pulmonary vein antrum isolation
EXPERIMENTAL: PVI + CFE	Procedure: PVI + CFE ablation; Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from AF	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.	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Atul Verma, Dr., Southlake Regional Health Centre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (ESTIMATE): September 16, 2010

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF-09-102-ID-AB