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Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study (Star AF II)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PVI + Lines ablation
PVI
PVI + CFE ablation
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • St. Andrews War Memorial Hospital
  • Southlake Regional Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

PVI + Lines Ablation

PVI Ablation

PVI + CFE

Arm Description

Outcomes

Primary Outcome Measures

Freedom from AF
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.

Secondary Outcome Measures

Freedom from atrial arrhythmia
Freedom from documented atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Freedom from atrial flutter and AT
Freedom from documented atrial flutter and atrial tachycardia episodes > 30 seconds at 18 months after one and two procedures with/without antiarrhythmic medications
Freedom from documented or not atrial arrhythmia
Freedom from any atrial arrhythmia (documented or not) episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Freedom from symptomatic AF
Freedom from symptomatic AF episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Freedom from symptomatic atrial arrhythmia
Freedom from symptomatic atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
Procedure duration and fluoroscopy time
Procedure duration and fluoroscopy time
Number of repeat procedures
Number of repeat procedures
Effect of each strategy on AF cycle length/regularity/termination
Effect of each strategy on AF cycle length/regularity/termination
Relationship of acute termination of AF to long-term procedural outcome
Relationship of acute termination of AF to long-term procedural outcome
Percentage achievement of complete linear block in linear ablation arm
Percentage achievement of complete linear block in linear ablation arm
Effect of complete linear block on procedural outcome in linear ablation arm
Effect of complete linear block on procedural outcome in linear ablation arm
Quality of life measurements (SF-36, EQ-5D and CCS SAF)
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
Correlation of AF burden to symptoms and quality of life changes
Correlation of AF burden to symptoms and quality of life changes
Improvement in AF burden by > 90% post ablation procedure
Improvement in AF burden by > 90% post ablation procedure
Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
Cut off of AF burden that affects the Quality of Life measurement
Cut off of AF burden that affects the Quality of Life measurement
Evaluation of cost utility
Evaluation of cost utility

Full Information

First Posted
September 15, 2010
Last Updated
January 28, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01203748
Brief Title
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Acronym
Star AF II
Official Title
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
589 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVI + Lines Ablation
Arm Type
Experimental
Arm Title
PVI Ablation
Arm Type
Active Comparator
Arm Title
PVI + CFE
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
PVI + Lines ablation
Intervention Description
Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)
Intervention Type
Procedure
Intervention Name(s)
PVI
Intervention Description
Pulmonary vein antrum isolation
Intervention Type
Procedure
Intervention Name(s)
PVI + CFE ablation
Intervention Description
Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation
Primary Outcome Measure Information:
Title
Freedom from AF
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Freedom from atrial arrhythmia
Description
Freedom from documented atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Time Frame
18 months
Title
Freedom from atrial flutter and AT
Description
Freedom from documented atrial flutter and atrial tachycardia episodes > 30 seconds at 18 months after one and two procedures with/without antiarrhythmic medications
Time Frame
18 months
Title
Freedom from documented or not atrial arrhythmia
Description
Freedom from any atrial arrhythmia (documented or not) episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Time Frame
18 months
Title
Freedom from symptomatic AF
Description
Freedom from symptomatic AF episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Time Frame
18 months
Title
Freedom from symptomatic atrial arrhythmia
Description
Freedom from symptomatic atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications
Time Frame
18 months
Title
Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
Description
Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death
Time Frame
18 months
Title
Procedure duration and fluoroscopy time
Description
Procedure duration and fluoroscopy time
Time Frame
18 months
Title
Number of repeat procedures
Description
Number of repeat procedures
Time Frame
18 months
Title
Effect of each strategy on AF cycle length/regularity/termination
Description
Effect of each strategy on AF cycle length/regularity/termination
Time Frame
18 months
Title
Relationship of acute termination of AF to long-term procedural outcome
Description
Relationship of acute termination of AF to long-term procedural outcome
Time Frame
18 months
Title
Percentage achievement of complete linear block in linear ablation arm
Description
Percentage achievement of complete linear block in linear ablation arm
Time Frame
18 months
Title
Effect of complete linear block on procedural outcome in linear ablation arm
Description
Effect of complete linear block on procedural outcome in linear ablation arm
Time Frame
18 months
Title
Quality of life measurements (SF-36, EQ-5D and CCS SAF)
Description
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
Time Frame
18 MONTHS
Title
Correlation of AF burden to symptoms and quality of life changes
Description
Correlation of AF burden to symptoms and quality of life changes
Time Frame
18 Months
Title
Improvement in AF burden by > 90% post ablation procedure
Description
Improvement in AF burden by > 90% post ablation procedure
Time Frame
18 months
Title
Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
Description
Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome
Time Frame
18 months
Title
Cut off of AF burden that affects the Quality of Life measurement
Description
Cut off of AF burden that affects the Quality of Life measurement
Time Frame
18 months
Title
Evaluation of cost utility
Description
Evaluation of cost utility
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Verma, Dr.
Organizational Affiliation
Southlake Regional Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Andrews War Memorial Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 8C3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33275151
Citation
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.
Results Reference
derived
PubMed Identifier
25946280
Citation
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.
Results Reference
derived
PubMed Identifier
22795275
Citation
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.
Results Reference
derived

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Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

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