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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PVI group

Trigger-based ablation guided by pulmonary vein antrum isolation

Group Type OTHER

Ablate AF triggers via PVI

Intervention Type PROCEDURE

Trigger-based ablation guided by pulmonary vein antrum isolation

CFAE group

Substrate-based ablation using an approach targeting CFAEs

Group Type OTHER

Substrate via CFAEs

Intervention Type PROCEDURE

Substrate-based ablation using an approach targeting CFAEs

Combined group

Combined trigger and substrate based approach

Group Type OTHER

Combined approach for AF ablation

Intervention Type PROCEDURE

Combined trigger and substrate based approach

Interventions

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Ablate AF triggers via PVI

Trigger-based ablation guided by pulmonary vein antrum isolation

Intervention Type PROCEDURE

Substrate via CFAEs

Substrate-based ablation using an approach targeting CFAEs

Intervention Type PROCEDURE

Combined approach for AF ablation

Combined trigger and substrate based approach

Intervention Type PROCEDURE

Eligibility Criteria

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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.

* 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