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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01203748




Registration number
NCT01203748
Ethics application status
Date submitted
15/09/2010
Date registered
16/09/2010
Date last updated
30/01/2019

Titles & IDs
Public title
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Scientific title
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Secondary ID [1] 0 0
AF-09-102-ID-AB
Universal Trial Number (UTN)
Trial acronym
Star AF II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - PVI + Lines ablation
Treatment: Surgery - PVI
Treatment: Surgery - PVI + CFE ablation

Experimental: PVI + Lines Ablation -

Active comparator: PVI Ablation -

Experimental: PVI + CFE -


Treatment: Surgery: PVI + Lines ablation
Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)

Treatment: Surgery: PVI
Pulmonary vein antrum isolation

Treatment: Surgery: PVI + CFE ablation
Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from AF
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Freedom from atrial arrhythmia
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Freedom from atrial flutter and AT
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Freedom from documented or not atrial arrhythmia
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Freedom from symptomatic AF
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
Freedom from symptomatic atrial arrhythmia
Timepoint [5] 0 0
18 months
Secondary outcome [6] 0 0
Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
Procedure duration and fluoroscopy time
Timepoint [7] 0 0
18 months
Secondary outcome [8] 0 0
Number of repeat procedures
Timepoint [8] 0 0
18 months
Secondary outcome [9] 0 0
Effect of each strategy on AF cycle length/regularity/termination
Timepoint [9] 0 0
18 months
Secondary outcome [10] 0 0
Relationship of acute termination of AF to long-term procedural outcome
Timepoint [10] 0 0
18 months
Secondary outcome [11] 0 0
Percentage achievement of complete linear block in linear ablation arm
Timepoint [11] 0 0
18 months
Secondary outcome [12] 0 0
Effect of complete linear block on procedural outcome in linear ablation arm
Timepoint [12] 0 0
18 months
Secondary outcome [13] 0 0
Quality of life measurements (SF-36, EQ-5D and CCS SAF)
Timepoint [13] 0 0
18 MONTHS
Secondary outcome [14] 0 0
Correlation of AF burden to symptoms and quality of life changes
Timepoint [14] 0 0
18 Months
Secondary outcome [15] 0 0
Improvement in AF burden by > 90% post ablation procedure
Timepoint [15] 0 0
18 months
Secondary outcome [16] 0 0
Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
Timepoint [16] 0 0
18 months
Secondary outcome [17] 0 0
Cut off of AF burden that affects the Quality of Life measurement
Timepoint [17] 0 0
18 months
Secondary outcome [18] 0 0
Evaluation of cost utility
Timepoint [18] 0 0
18 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
589
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
St. Andrews War Memorial Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01203748
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Atul Verma, Dr.
Address 0 0
Southlake Regional Health Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01203748