Back to resultsSTrategies for Catheter Ablation of peRsistent Atrial Fibrlllation (STARAF3)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring ablation
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years of age or older
- Patients undergoing first-time ablation procedure for AF
- Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
- 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
- Patients whose AF has been refractory to at least one antiarrhythmic drug
- 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
- Patients must be able and willing to provide written informed consent to participate in the study
Exclusion Criteria:
- Patients with paroxysmal AF (no episodes lasting > 7 days)
- Patients with early persistent AF, sustained episode ≤ 3 months
- Patients with very long lasting persistent AF (episodes lasting > 3 years)
- Patients with CHA2DS2-VASc score of 0.
- 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 contraindication to oral anticoagulation or systemic anticoagulation with heparin
- Patients with left atrial diameter > 60 mm in the parasternal long axis view
- Patients who are pregnant
Sites / Locations
- Royal Adelaide Hospital and Cardiovascular CentreRecruiting
- Medical University of GrazRecruiting
- Ordensklinikum Linz GmbHRecruiting
- OLV Hospital AalstRecruiting
- Antwerp University Hospital (UZA)Recruiting
- University of Calgary FoothillsRecruiting
- Vancouver General HospitalRecruiting
- St. Paul's Hospital, Vancouver, BCRecruiting
- Royal Jubilee HospitalRecruiting
- Hamilton General HospitalRecruiting
- Southlake Regional Health CenterRecruiting
- Laurent MacleRecruiting
- MUHC, McGill University Health CentreRecruiting
- Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)Recruiting
- Hôpital Fleurimont, CHUSRecruiting
- Hospital St-JosephRecruiting
- CHU Arnaud de VilleneuveRecruiting
- Institut Mutualiste MontsourisRecruiting
- Clinique PasteurRecruiting
- Clinique du TonkinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
PV antral isolation alone (PVAI)
PV antral isolation plus ablation of drivers
PV antral isolation plus isolation of posterior wall
Arm Description
PV antral isolation alone (PVAI)
PV antral isolation plus ablation of drivers (PVAI+drivers)
PV antral isolation plus isolation of LA posterior wall (PVAI+Box)
Outcomes
Primary Outcome Measures
Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).
Secondary Outcome Measures
Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM
Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM
Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM
Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM
Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM
Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM
Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM
Each of the above success measures stratified by CHA2DS2-VASc score
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death
Procedure duration
Fluoroscopy time (dose)
Radiofrequency time
Number of repeat procedures
Effect of each strategy on AF cycle length changes and AF termination
Correlation of acute AF termination on long-term procedural outcome
Quality of life measurements during follow-up using AFEQT questionnaire
AFEQT questionnaires will be used at baseline, 6, 12 and 18 months
Quality of life measurements during follow-up using SF36 questionnaires
SF36 questionnaires will be used at baseline, 6, 12 and 18 months
Change in AF burden post-ablation procedure (% of time in AF)
Full Information
NCT ID
NCT04428944
First Posted
June 5, 2020
Last Updated
February 13, 2023
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Montreal Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT04428944
Brief Title
STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation
Acronym
STARAF3
Official Title
Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Montreal Heart Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF:
PV antral isolation alone (PVAI)
PV antral isolation plus ablation of drivers (PVAI+drivers)
PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PV antral isolation alone (PVAI)
Arm Type
Active Comparator
Arm Description
PV antral isolation alone (PVAI)
Arm Title
PV antral isolation plus ablation of drivers
Arm Type
Active Comparator
Arm Description
PV antral isolation plus ablation of drivers (PVAI+drivers)
Arm Title
PV antral isolation plus isolation of posterior wall
Arm Type
Active Comparator
Arm Description
PV antral isolation plus isolation of LA posterior wall (PVAI+Box)
Intervention Type
Procedure
Intervention Name(s)
Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
Intervention Description
Standard PVI
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
Intervention Description
Standard PVI + Ablation of drivers in LA and RA
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)
Intervention Description
Standard PVI + Electrical isolation of the posterior wall of the left atrium
Primary Outcome Measure Information:
Title
Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM
Time Frame
18 months
Title
Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM
Time Frame
18 months
Title
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM
Time Frame
18 months
Title
Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM
Time Frame
18 months
Title
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM
Time Frame
18 months
Title
Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM
Time Frame
18 months
Title
Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM
Time Frame
18 months
Title
Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM
Time Frame
18 months
Title
Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM
Time Frame
18 months
Title
Each of the above success measures stratified by CHA2DS2-VASc score
Time Frame
18 months
Title
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death
Time Frame
18 months
Title
Procedure duration
Time Frame
18 months
Title
Fluoroscopy time (dose)
Time Frame
18 months
Title
Radiofrequency time
Time Frame
18 months
Title
Number of repeat procedures
Time Frame
18 months
Title
Effect of each strategy on AF cycle length changes and AF termination
Time Frame
18 months
Title
Correlation of acute AF termination on long-term procedural outcome
Time Frame
18 months
Title
Quality of life measurements during follow-up using AFEQT questionnaire
Description
AFEQT questionnaires will be used at baseline, 6, 12 and 18 months
Time Frame
6-12-18 months
Title
Quality of life measurements during follow-up using SF36 questionnaires
Description
SF36 questionnaires will be used at baseline, 6, 12 and 18 months
Time Frame
6-12-18 months
Title
Change in AF burden post-ablation procedure (% of time in AF)
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years of age or older
Patients undergoing first-time ablation procedure for AF
Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
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
Patients whose AF has been refractory to at least one antiarrhythmic drug
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
Patients must be able and willing to provide written informed consent to participate in the study
Exclusion Criteria:
Patients with paroxysmal AF (no episodes lasting > 7 days)
Patients with early persistent AF, sustained episode ≤ 3 months
Patients with very long lasting persistent AF (episodes lasting > 3 years)
Patients with CHA2DS2-VASc score of 0.
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 contraindication to oral anticoagulation or systemic anticoagulation with heparin
Patients with left atrial diameter > 60 mm in the parasternal long axis view
Patients who are pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Morello
Phone
514-376-3330
Ext
6279
Email
mary.morello@icm-mhi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Verma, Dr.
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurent Macle, Dr.
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital and Cardiovascular Centre
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prashanthan Sanders, MD
Facility Name
Medical University of Graz
City
Graz,
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Scherr, MD
Facility Name
Ordensklinikum Linz GmbH
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helmut Pürerfellner, MD
Facility Name
OLV Hospital Aalst
City
Aalst
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom De Potter, MD
Facility Name
Antwerp University Hospital (UZA)
City
Edegem
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Sarkozy, MD
Facility Name
University of Calgary Foothills
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Morillo, MD
Facility Name
Vancouver General Hospital
City
Vancouver,
State/Province
British Colombia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Andrade, MD
Facility Name
St. Paul's Hospital, Vancouver, BC
City
Vancouver
State/Province
British Colombia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Deyell, MD
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Colombia
ZIP/Postal Code
V8R 1J8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Novak, MD
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Amit, MD
Facility Name
Southlake Regional Health Center
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mouhannad Sadek, MD
Facility Name
Laurent Macle
City
Montreal
State/Province
QC - Québec
ZIP/Postal Code
H1T 1c8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Macle, MD
Phone
5143763330
First Name & Middle Initial & Last Name & Degree
Mary Morello
Phone
5143763330
Ext
6279
Email
mary.morello@icm-mhi.org
Facility Name
MUHC, McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vidal Essebag, MD
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Champagne, MD
Facility Name
Hôpital Fleurimont, CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5H3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Roux, MD
Facility Name
Hospital St-Joseph
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Pasquié, MD
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Sebag, MD
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Albenque, MD
Facility Name
Clinique du Tonkin
City
Villeurbanne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyril Durand, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation
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