N/A N=350 Randomized Diagnostic

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

Persistent Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT02274857 ↗

Enrolled (actual)

350

Serious AEs

13.4%

Results posted

Feb 2020

Primary outcome: Primary: Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure — 92.7; 88.9 % of participants — p=0.2179

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Standard PVI Ablation (Procedure); FIRM-Guided Procedure and PVI (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Devices
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure	92.7; 88.9	0.2179
PRIMARY Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.	76.9; 71.8	0.2782
PRIMARY Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.	67.5; 69.3	0.7266
PRIMARY Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure	146; 144	0.3522
SECONDARY 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	86.1	—

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02274857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.