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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01203748