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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01203748
First received: September 15, 2010
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: PVI + Lines ablation
Procedure: PVI
Procedure: PVI + CFE ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from AF [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death

  • Procedure duration and fluoroscopy time [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Procedure duration and fluoroscopy time

  • Number of repeat procedures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Number of repeat procedures

  • Effect of each strategy on AF cycle length/regularity/termination [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Effect of each strategy on AF cycle length/regularity/termination

  • Relationship of acute termination of AF to long-term procedural outcome [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Relationship of acute termination of AF to long-term procedural outcome

  • Percentage achievement of complete linear block in linear ablation arm [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Percentage achievement of complete linear block in linear ablation arm

  • Effect of complete linear block on procedural outcome in linear ablation arm [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Effect of complete linear block on procedural outcome in linear ablation arm

  • Quality of life measurements (SF-36, EQ-5D and CCS SAF) [ Time Frame: 18 MONTHS ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
    Correlation of AF burden to symptoms and quality of life changes

  • Improvement in AF burden by > 90% post ablation procedure [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Cut off of AF burden that affects the Quality of Life measurement

  • Evaluation of cost utility [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Evaluation of cost utility


Enrollment: 589
Study Start Date: November 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVI + Lines Ablation Procedure: PVI + Lines ablation
Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)
Active Comparator: PVI Ablation Procedure: PVI
Pulmonary vein antrum isolation
Experimental: PVI + CFE Procedure: PVI + CFE ablation
Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203748

Locations
Australia, Queensland
St. Andrews War Memorial Hospital
Brisbane, Queensland, Australia
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 8C3
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Atul Verma, Dr. Southlake Regional Health Centre
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01203748     History of Changes
Other Study ID Numbers: AF-09-102-ID-AB
Study First Received: September 15, 2010
Last Updated: January 30, 2014
Health Authority: Canada: Health Canada
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014