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

Persistent Atrial Fibrillation Clinical Trial

— REAFFIRM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274857
• Other study ID #: REAFFIRM
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 10, 2018

Study information

• Verified date: February 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: November 10, 2018
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Standard PVI Ablation
Standard PVI procedure without FIRMap.
• FIRM-Guided Procedure and PVI
FIRM-guided procedure followed by conventional ablation including PVI.

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum Bad Oeynhausen	Bad Oeynhausen	Minden-Lübbecke
Germany	Unfallkrankenhaus Berlin	Berlin
Germany	Klinikum Coburg GmbH	Coburg
Germany	Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR	Dresden
Germany	Städtisches Klinikum Karlsruhe gGmbH	Karlsruhe
Germany	Leipzig Heart Institute GmbH	Leipzig
Germany	Kardiologische Gemeinschaftspraxis am Park Sanssouci	Potsdam
Netherlands	Erasmus Medical Center	Rotterdam
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	The Ohio State University	Columbus	Ohio
United States	Hackensack UMC	Hackensack	New Jersey
United States	Indiana University - Krannert Institute of Cardiology	Indianapolis	Indiana
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Loyola University Medical Center	Maywood	Illinois
United States	Weill Medical College at Cornell University	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Arizona Heart Rhythm Center	Phoenix	Arizona
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure		Within 7-10 days of the Procedure
Primary	Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.		3-month follow up
Primary	Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.		3-12 months post study treatment
Primary	Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure		3 to 12 months post study treatment
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		Immediately post procedure