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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
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Secondary ID [1]
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AF-09-102-ID-AB
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Universal Trial Number (UTN)
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Trial acronym
Star AF II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Freedom from AF
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Assessment method [1]
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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.
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Timepoint [1]
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18 months
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Secondary outcome [1]
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Freedom from atrial arrhythmia
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Assessment method [1]
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Freedom from documented atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
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Timepoint [1]
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18 months
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Secondary outcome [2]
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Freedom from atrial flutter and AT
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Assessment method [2]
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Freedom from documented atrial flutter and atrial tachycardia episodes > 30 seconds at 18 months after one and two procedures with/without antiarrhythmic medications
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Timepoint [2]
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18 months
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Secondary outcome [3]
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Freedom from documented or not atrial arrhythmia
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Assessment method [3]
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Freedom from any atrial arrhythmia (documented or not) episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
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Timepoint [3]
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18 months
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Secondary outcome [4]
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Freedom from symptomatic AF
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Assessment method [4]
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Freedom from symptomatic AF episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
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Timepoint [4]
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18 months
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Secondary outcome [5]
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Freedom from symptomatic atrial arrhythmia
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Assessment method [5]
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Freedom from symptomatic atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
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Timepoint [5]
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18 months
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Secondary outcome [6]
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Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
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Assessment method [6]
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Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
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Timepoint [6]
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18 months
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Secondary outcome [7]
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Procedure duration and fluoroscopy time
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Assessment method [7]
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Procedure duration and fluoroscopy time
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Timepoint [7]
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18 months
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Secondary outcome [8]
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Number of repeat procedures
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Assessment method [8]
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Number of repeat procedures
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Timepoint [8]
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18 months
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Secondary outcome [9]
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Effect of each strategy on AF cycle length/regularity/termination
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Assessment method [9]
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Effect of each strategy on AF cycle length/regularity/termination
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Timepoint [9]
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18 months
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Secondary outcome [10]
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Relationship of acute termination of AF to long-term procedural outcome
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Assessment method [10]
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Relationship of acute termination of AF to long-term procedural outcome
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Timepoint [10]
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18 months
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Secondary outcome [11]
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Percentage achievement of complete linear block in linear ablation arm
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Assessment method [11]
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Percentage achievement of complete linear block in linear ablation arm
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Timepoint [11]
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18 months
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Secondary outcome [12]
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Effect of complete linear block on procedural outcome in linear ablation arm
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Assessment method [12]
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Effect of complete linear block on procedural outcome in linear ablation arm
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Timepoint [12]
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18 months
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Secondary outcome [13]
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Quality of life measurements (SF-36, EQ-5D and CCS SAF)
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Assessment method [13]
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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
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Timepoint [13]
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18 MONTHS
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Secondary outcome [14]
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Correlation of AF burden to symptoms and quality of life changes
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Assessment method [14]
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Correlation of AF burden to symptoms and quality of life changes
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Timepoint [14]
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18 Months
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Secondary outcome [15]
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Improvement in AF burden by > 90% post ablation procedure
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Assessment method [15]
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Improvement in AF burden by > 90% post ablation procedure
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Timepoint [15]
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18 months
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Secondary outcome [16]
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Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
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Assessment method [16]
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Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
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Timepoint [16]
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18 months
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Secondary outcome [17]
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Cut off of AF burden that affects the Quality of Life measurement
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Assessment method [17]
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Cut off of AF burden that affects the Quality of Life measurement
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Timepoint [17]
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18 months
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Secondary outcome [18]
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Evaluation of cost utility
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Assessment method [18]
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Evaluation of cost utility
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Timepoint [18]
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18 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2014
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Sample size
Target
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Accrual to date
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Final
589
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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St. Andrews War Memorial Hospital - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01203748
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Atul Verma, Dr.
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Address
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Southlake Regional Health Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01203748
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