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

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

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).

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Standard PVI Ablation; Procedure: FIRM-Guided Procedure and PVI

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12683
    • Unfallkrankenhaus Berlin
  • Coburg, Germany, 96450
    • Klinikum Coburg GmbH
  • Dresden, Germany, 01099
    • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
  • Karlsruhe, Germany
    • Städtisches Klinikum Karlsruhe gGmbH
  • Leipzig, Germany, 04289
    • Leipzig Heart Institute GmbH
  • Potsdam, Germany, 14471
    • Kardiologische Gemeinschaftspraxis am Park Sanssouci
  • Minden-Lübbecke
    • Bad Oeynhausen, Minden-Lübbecke, Germany, 32545
      • Herz- und Diabeteszentrum Bad Oeynhausen
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Arizona Heart Rhythm Center
  • California
    • Newport Beach, California, United States, 92658
      • Hoag Memorial Hospital Presbyterian
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana University - Krannert Institute of Cardiology
  • Maryland
    • Baltimore, Maryland, United States
      • The Johns Hopkins Hospital
  • New Jersey
    • Hackensack, New Jersey, United States
      • Hackensack UMC
  • New York
    • New York, New York, United States, 10065
      • Weill Medical College at Cornell University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States
      • Geisinger Wyoming Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard PVI Ablation; Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.	Procedure: Standard PVI Ablation; Standard PVI procedure without FIRMap.; Other Names: Pulmonary vein isolation; Ablation; Arrhythmia; Mapping; Persistent atrial fibrillation
Experimental: FIRM-guided Procedure and PVI; FIRM-guided procedure followed by standard catheter ablation including PVI.	Procedure: FIRM-Guided Procedure and PVI; FIRM-guided procedure followed by conventional ablation including PVI.; Other Names: Pulmonary vein isolation; Ablation; Arrhythmia; Mapping; FIRMap; Persistent atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure	Within 7-10 days of the Procedure
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.	3-month follow up
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.	3-12 months post study treatment
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Johannes Brachmann, MD, Klinikum Coburg GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): November 10, 2018
• Study Completion (Actual): November 10, 2018

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Rotor; Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap); FIRM-guided procedure; REAFFIRM
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: REAFFIRM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO