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

NCT00367757 | Completed

• 1 other identifier: AF06002AF
• Study Type: interventional
• Target: 107
• Locations: 4 countries
• Sites: 8

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.

  3 months

• Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.

  12 months

Secondary Outcomes (6)

• Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.

  12 months

• Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.

  12 months

• Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.

  12 months

• Procedure duration at ablation.

  At intervention

• Fluoroscopy time at ablation.

  At intervention

Study Arms (3)

PVI group

OTHER

Trigger-based ablation guided by pulmonary vein antrum isolation

Procedure: Ablate AF triggers via PVI

CFAE group

OTHER

Substrate-based ablation using an approach targeting CFAEs

Procedure: Substrate via CFAEs

Combined group

OTHER

Combined trigger and substrate based approach

Procedure: Combined approach for AF ablation

Interventions

Ablate AF triggers via PVI PROCEDURE

Trigger-based ablation guided by pulmonary vein antrum isolation

PVI group

Substrate via CFAEs PROCEDURE

Substrate-based ablation using an approach targeting CFAEs

CFAE group

Combined approach for AF ablation PROCEDURE

Combined trigger and substrate based approach

Combined group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• chronic atrial fibrillation.
• Patients with AF felt to be secondary to an obvious reversible cause.
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (8)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Montreal Heaert Institute

Montreal, Quebec, H1T 1C8, Canada

Location

McMaster University

Hamilton, L8L 2X2, Canada

Location

Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee

Victoria, V8R 4R2, Canada

Location

Clinica Santa Maria

Bari, Apulia, 70124, Italy

Location

Ospedale Regionale Ca'Foncello

Treviso, 31100, Italy

Location

Haukeland Universitetssykehus

Bergen, Haukeland, 5021, Norway

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (1)

• Verma A, Mantovan R, Macle L, De Martino G, Chen J, Morillo CA, Novak P, Calzolari V, Guerra PG, Nair G, Torrecilla EG, Khaykin Y. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial. Eur Heart J. 2010 Jun;31(11):1344-56. doi: 10.1093/eurheartj/ehq041. Epub 2010 Mar 9.

  PMID: 20215126 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Atul Verma, Dr.

  Southlake Regional health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 23, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

CA (4); NO (1); IT (2); ES (1)