NCT02274857

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

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT02274857

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

Summary

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).

Eligibility

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.

Disease(s) and\or Condition(s)

Persistent Atrial Fibrillation

Primary Purpose

DIAGNOSTIC

Intervention/Treatment

- Type: PROCEDURE
- Name: Standard PVI Ablation
- Description: Standard PVI procedure without FIRMap.
- Arm Group Labels: Standard PVI Ablation
- Type: PROCEDURE
- Name: FIRM-Guided Procedure and PVI
- Description: FIRM-guided procedure followed by conventional ablation including PVI.
- Arm Group Labels: FIRM-guided Procedure and PVI

Sponsor

Abbott Medical Devices