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

January 28, 2019 updated by: Abbott Medical Devices

Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Hamilton, Canada, L8L 2X2
        • McMaster University
      • Victoria, Canada, V8R 4R2
        • Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heaert Institute
  • Italy
      • Treviso, Italy, 31100
        • Ospedale Regionale Ca'Foncello
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Clínica Santa María
  • Norway
    • Haukeland
      • Bergen, Haukeland, Norway, 5021
        • Haukeland Universitetssykehus
  • Spain
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: CFAE group
Substrate-based ablation using an approach targeting CFAEs
Procedure: Substrate via CFAEs
Substrate-based ablation using an approach targeting CFAEs
Other: Combined group
Combined trigger and substrate based approach
Procedure: Combined approach for AF ablation
Combined trigger and substrate based approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.
Time Frame: 3 months
3 months
Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.
Time Frame: 12 months
12 months
Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.
Time Frame: 12 months
12 months
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.
Time Frame: 12 months
12 months
Procedure duration at ablation.
Time Frame: At intervention
At intervention
Fluoroscopy time at ablation.
Time Frame: At intervention
At intervention
Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Atul Verma, Dr., Southlake Regional Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 22, 2006

First Submitted That Met QC Criteria

August 22, 2006

First Posted (Estimate)

August 23, 2006

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF06002AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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