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

Atrial Fibrillation Clinical Trial

— Star AF II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203748
• Other study ID #: AF-09-102-ID-AB
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• PVI + Lines ablation
Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)
• PVI
Pulmonary vein antrum isolation
• PVI + CFE ablation
Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

Locations

Country	Name	City	State
Australia	St. Andrews War Memorial Hospital	Brisbane	Queensland
Canada	Southlake Regional Health Centre	Newmarket	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Procedure duration and fluoroscopy time	Procedure duration and fluoroscopy time	18 months
Secondary	Number of repeat procedures	Number of repeat procedures	18 months
Secondary	Effect of each strategy on AF cycle length/regularity/termination	Effect of each strategy on AF cycle length/regularity/termination	18 months
Secondary	Relationship of acute termination of AF to long-term procedural outcome	Relationship of acute termination of AF to long-term procedural outcome	18 months
Secondary	Percentage achievement of complete linear block in linear ablation arm	Percentage achievement of complete linear block in linear ablation arm	18 months
Secondary	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
Secondary	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
Secondary	Correlation of AF burden to symptoms and quality of life changes	Correlation of AF burden to symptoms and quality of life changes	18 Months
Secondary	Improvement in AF burden by > 90% post ablation procedure	Improvement in AF burden by > 90% post ablation procedure	18 months
Secondary	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
Secondary	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
Secondary	Evaluation of cost utility	Evaluation of cost utility	18 months