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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04428944




Registration number
NCT04428944
Ethics application status
Date submitted
5/06/2020
Date registered
11/06/2020

Titles & IDs
Public title
STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation
Scientific title
Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study
Secondary ID [1] 0 0
MP-33-2021-2805
Universal Trial Number (UTN)
Trial acronym
STARAF3
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 - Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
Treatment: Surgery - Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
Treatment: Surgery - Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)

Active comparator: PV antral isolation alone (PVAI) - PV antral isolation alone (PVAI)

Active comparator: PV antral isolation plus ablation of drivers - PV antral isolation plus ablation of drivers (PVAI+drivers)

Active comparator: PV antral isolation plus isolation of posterior wall - PV antral isolation plus isolation of LA posterior wall (PVAI+Box)


Treatment: Surgery: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
Standard PVI

Treatment: Surgery: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
Standard PVI + Ablation of drivers in LA and RA

Treatment: Surgery: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)
Standard PVI + Electrical isolation of the posterior wall of the left atrium
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from documented atrial arrhythmia = 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM
Timepoint [5] 0 0
18 months
Secondary outcome [6] 0 0
Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM
Timepoint [7] 0 0
18 months
Secondary outcome [8] 0 0
Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM
Timepoint [8] 0 0
18 months
Secondary outcome [9] 0 0
Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM
Timepoint [9] 0 0
18 months
Secondary outcome [10] 0 0
Each of the above success measures stratified by CHA2DS2-VASc score
Timepoint [10] 0 0
18 months
Secondary outcome [11] 0 0
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death
Timepoint [11] 0 0
18 months
Secondary outcome [12] 0 0
Procedure duration
Timepoint [12] 0 0
18 months
Secondary outcome [13] 0 0
Fluoroscopy time (dose)
Timepoint [13] 0 0
18 months
Secondary outcome [14] 0 0
Radiofrequency time
Timepoint [14] 0 0
18 months
Secondary outcome [15] 0 0
Number of repeat procedures
Timepoint [15] 0 0
18 months
Secondary outcome [16] 0 0
Effect of each strategy on AF cycle length changes and AF termination
Timepoint [16] 0 0
18 months
Secondary outcome [17] 0 0
Correlation of acute AF termination on long-term procedural outcome
Timepoint [17] 0 0
18 months
Secondary outcome [18] 0 0
Quality of life measurements during follow-up using AFEQT questionnaire
Timepoint [18] 0 0
6-12-18 months
Secondary outcome [19] 0 0
Quality of life measurements during follow-up using SF12 questionnaires
Timepoint [19] 0 0
6-12-18 months
Secondary outcome [20] 0 0
Change in AF burden post-ablation procedure (% of time in AF)
Timepoint [20] 0 0
18 months

Eligibility
Key inclusion criteria
1. Patients 18 years of age or older
2. Patients undergoing first-time ablation procedure for AF
3. Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
4. Patients with symptomatic AF - symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms or any combination of the above
5. Patients whose AF has been refractory to at least one antiarrhythmic drug
6. At least one episode of AF must have been documented by ECG, holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within the last 2 years from enrolment
7. Patients must be able and willing to provide written informed consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with paroxysmal AF (no episodes lasting > 7 days)
2. Patients with early persistent AF, sustained episode = 3 months
3. Patients with very long lasting persistent AF (episodes lasting > 3 years)
4. Patients with CHA2DS2-VASc score of 0.
5. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
6. Patients with AF felt to be secondary to an obvious reversible cause
7. Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin
8. Patients with left atrial diameter > 60 mm in the parasternal long axis view
9. 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
615
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
Canberra Heart Rhythm Foundation - Garran
Recruitment hospital [2] 0 0
Royal Adelaide Hospital and Cardiovascular Centre - Adelaide
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
Austria
State/province [3] 0 0
Graz,
Country [4] 0 0
Austria
State/province [4] 0 0
Linz
Country [5] 0 0
Belgium
State/province [5] 0 0
Aalst
Country [6] 0 0
Belgium
State/province [6] 0 0
Edegem
Country [7] 0 0
Belgium
State/province [7] 0 0
Ruddershove
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Colombia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
QC - Québec
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Montpellier
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
France
State/province [17] 0 0
Villeurbanne
Country [18] 0 0
Italy
State/province [18] 0 0
Acquaviva delle Fonti
Country [19] 0 0
Japan
State/province [19] 0 0
Saitama
Country [20] 0 0
Japan
State/province [20] 0 0
Tokyo
Country [21] 0 0
Japan
State/province [21] 0 0
Chuo Ku
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Other
Name
McGill University Health Centre/Research Institute of the McGill University Health Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Montreal Heart Institute
Address [1] 0 0
Country [1] 0 0

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
McGill University Health Centre/Research Institute of the McGill University Health Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Caroline Girard
Address 0 0
Country 0 0
Phone 0 0
514-376-3330
Fax 0 0
Email 0 0
caroline.girard@icm-mhi.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT04428944