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

Abbott

Status: Completed

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: FIRM-Guided Procedure and PVI; Procedure: Standard PVI Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02274857

REAFFIRM

Details and patient eligibility

About

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).

Enrollment: 350 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Standard PVI Ablation

Active Comparator group

Description:

Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.

Treatment:

Procedure: Standard PVI Ablation

FIRM-guided Procedure and PVI

Experimental group

Description:

FIRM-guided procedure followed by standard catheter ablation including PVI.

Treatment:

Procedure: FIRM-Guided Procedure and PVI