Clinical trial NCT02274857: Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Official title: Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap)
Rotor
FIRM-guided procedure
REAFFIRM
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Primary outcomes:
measure: Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
timeFrame: Within 7-10 days of the Procedure
measure: Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
timeFrame: 3-month follow up
measure: Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
timeFrame: 3-12 months post study treatment
measure: Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
timeFrame: 3 to 12 months post study treatment
Secondary outcomes:
measure: 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
timeFrame: Immediately post procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Rhythm Center
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University - Krannert Institute of Cardiology
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Hackensack
country: United States
facility: Hackensack UMC
state: New Jersey
city: New York
country: United States
facility: Weill Medical College at Cornell University
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Bad Oeynhausen
state: Minden-Lübbecke
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Dresden
country: Germany
facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH
city: Leipzig
country: Germany
facility: Leipzig Heart Institute GmbH
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Klinikum Coburg GmbH
name: Johannes Brachmann, MD
role: PRINCIPAL_INVESTIGATOR
References: