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STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00367757
First received: August 22, 2006
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  Purpose

Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months terminated by cardioversion or drug).

Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation


Condition Intervention
Atrial Fibrillation
 Procedure: Ablate AF triggers via PVI
Procedure: Substrate via CFAEs
Procedure: Combined approach for AF ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Procedure duration at ablation. [ Time Frame: At intervention ] [ Designated as safety issue: No ]
  • Fluoroscopy time at ablation. [ Time Frame: At intervention ] [ Designated as safety issue: No ]
  • Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PVI group
Trigger-based ablation guided by pulmonary vein antrum isolation
 Procedure: Ablate AF triggers via PVI
Trigger-based ablation guided by pulmonary vein antrum isolation
CFAE group
Substrate-based ablation using an approach targeting CFAEs
 Procedure: Substrate via CFAEs
Substrate-based ablation using an approach targeting CFAEs
Combined group
Combined trigger and substrate based approach
 Procedure: Combined approach for AF ablation
Combined trigger and substrate based approach

Detailed Description:

Interventions: Patients will be randomized to either wide circumferential pulmonary vein isolation ("trigger") or ablation of high-frequency, fractionated electrograms during AF ("substrate"), or a hybrid approach combining trigger and substrate. Both techniques will be performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed within 6 months. A 2 month blanking period will be allowed after each procedure during which early recurrences will not be counted.

Outcomes:

  • Recurrence of atrial fibrillation or other atrial tachycardia at 3, 6, and 12 months post-initial procedure.
  • Recurrence will be defined by symptoms and/or ECG/Holter data showing AF > 2 mins
  • Occurrence of adverse events in each group post-procedure.
  • Quality of life assessment at 6 and 12 months post-initial procedure.

Followup:

  • 3, 6, and 12 months post-initial procedure.
  • Clinical data, ECG, Holter, loop recorder at baseline and at each visit.
  • QOL at baseline, 3, 6 and 12 months post-initial procedure.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 18 or greater.
  • "high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
  • candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
  • At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
  • continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation.
  • Patients must be able and willing to provide written informed consent to participate in the clinical trial.

Exclusion Criteria:

  • chronic atrial fibrillation.
  • Patients with AF felt to be secondary to an obvious reversible cause.
  • inadequate anticoagulation as defined in the inclusion criteria.
  • left atrial thrombus or spontaneous echo contrast on TEE prior to procedure.
  • contraindications to systemic anticoagulation with heparin or coumadin.
  • previously undergone atrial fibrillation ablation.
  • left atrial size > 55 mm.
  • Patients who are or may potentially be pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367757

Locations
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Quebec
Montreal Heaert Institute
Montreal, Quebec, Canada, H1T 1C8
Canada
McMaster University
Hamilton, Canada, L8L 2X2
Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee
Victoria, Canada, V8R 4R2
Italy
Clinica Santa Maria
Bari, Apulia, Italy, 70124
Ospedale Regionale Ca'Foncello
Treviso, Italy, 31100
Norway
Haukeland Universitetssykehus
Bergen, Haukeland, Norway, 5021
Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Atul Verma, Dr. Southlake Regional Health Center
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Atul Verma, Southlake Regional Health Centre, Southlake, Canada
ClinicalTrials.gov Identifier: NCT00367757     History of Changes
Other Study ID Numbers: AF06002AF
Study First Received: August 22, 2006
Last Updated: July 30, 2009
Health Authority: Canada: Health Canada

Keywords provided by St. Jude Medical:
paroxysmal atrial fibrillation
persistent atrial fibrillation
high burden of atrial fibrillation
atrial fibrillation ablation
Pulmonary vein isolation
AF trigger
complex fractionated electrograms
CFE
CFAE
complex fractionated atrial electrograms
 refractory antiarrhythmic medication
PVAI
Ensite NavX
NavX
CoolPath catheter
irrigated ablation catheter
high burden of paroxysmal or persistent atrial fibrillation
candidates for AF ablation
symptomatic AF
AF is refractory to at least one antiarrhythmic medication

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013