Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

Abbott Medical Devices350 enrolled

Overview

The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

350

Conditions

Persistent Atrial Fibrillation

Interventions

Standard PVI AblationPROCEDURE

Standard PVI procedure without FIRMap.

FIRM-Guided Procedure and PVIPROCEDURE

FIRM-guided procedure followed by conventional ablation including PVI.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months * Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications * Left atrial diameter \< 6.0 cm Key Exclusion Criteria: * Previous AF Ablation * Presence of structural heart disease * New York Heart Association (NYHA) Class IV. * Ejection fraction \< 35%. * History of myocardial infarction (MI) within the past three months.

Locations (18)

Arizona Heart Rhythm Center

Phoenix, Arizona, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Outcomes

Primary Outcomes

Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure

Time frame: Within 7-10 days of the Procedure

Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.

Time frame: 3-month follow up

Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.

Time frame: 3-12 months post study treatment

Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure

Time frame: 3 to 12 months post study treatment

Secondary Outcomes

Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts

Time frame: Immediately post procedure

Data from ClinicalTrials.gov

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