Substrate and 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

589 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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

SINGLE

Participants

Study Groups

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PVI + Lines Ablation

Group Type EXPERIMENTAL

PVI + Lines ablation

Intervention Type PROCEDURE

Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)

PVI Ablation

Group Type ACTIVE_COMPARATOR

PVI

Intervention Type PROCEDURE

Pulmonary vein antrum isolation

PVI + CFE

Group Type EXPERIMENTAL

PVI + CFE ablation

Intervention Type PROCEDURE

Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

Interventions

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PVI + Lines ablation

Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)

Intervention Type PROCEDURE

PVI

Pulmonary vein antrum isolation

Intervention Type PROCEDURE

PVI + CFE ablation

Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No