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

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard PVI Ablation
FIRM-Guided Procedure and PVI
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Persistent Atrial Fibrillation focused on measuring Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap), Rotor, FIRM-guided procedure, REAFFIRM

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Heart Rhythm Center
  • Hoag Memorial Hospital Presbyterian
  • Loyola University Medical Center
  • Indiana University - Krannert Institute of Cardiology
  • St. Vincent Hospital
  • The Johns Hopkins Hospital
  • Hackensack UMC
  • Weill Medical College at Cornell University
  • The Ohio State University
  • Geisinger Wyoming Valley Medical Center
  • Herz- und Diabeteszentrum Bad Oeynhausen
  • Unfallkrankenhaus Berlin
  • Klinikum Coburg GmbH
  • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
  • Städtisches Klinikum Karlsruhe gGmbH
  • Leipzig Heart Institute GmbH
  • Kardiologische Gemeinschaftspraxis am Park Sanssouci
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard PVI Ablation

FIRM-guided Procedure and PVI

Arm Description

Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.

FIRM-guided procedure followed by standard catheter ablation including PVI.

Outcomes

Primary Outcome Measures

Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2014
Last Updated
February 3, 2020
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02274857
Brief Title
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Acronym
REAFFIRM
Official Title
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 10, 2018 (Actual)
Study Completion Date
November 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap), Rotor, FIRM-guided procedure, REAFFIRM

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard PVI Ablation
Arm Type
Active Comparator
Arm Description
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Arm Title
FIRM-guided Procedure and PVI
Arm Type
Experimental
Arm Description
FIRM-guided procedure followed by standard catheter ablation including PVI.
Intervention Type
Procedure
Intervention Name(s)
Standard PVI Ablation
Other Intervention Name(s)
Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation, Mapping
Intervention Description
Standard PVI procedure without FIRMap.
Intervention Type
Procedure
Intervention Name(s)
FIRM-Guided Procedure and PVI
Other Intervention Name(s)
Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation, Mapping, FIRMap
Intervention Description
FIRM-guided procedure followed by conventional ablation including PVI.
Primary Outcome Measure Information:
Title
Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
Time Frame
Within 7-10 days of the Procedure
Title
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
Time Frame
3-month follow up
Title
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
Time Frame
3-12 months post study treatment
Title
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
Time Frame
3 to 12 months post study treatment
Secondary Outcome Measure Information:
Title
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
Time Frame
Immediately post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Brachmann, MD
Organizational Affiliation
Klinikum Coburg GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Heart Rhythm Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University - Krannert Institute of Cardiology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Hackensack UMC
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Weill Medical College at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
Country
United States
Facility Name
Herz- und Diabeteszentrum Bad Oeynhausen
City
Bad Oeynhausen
State/Province
Minden-Lübbecke
ZIP/Postal Code
32545
Country
Germany
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
ZIP/Postal Code
12683
Country
Germany
Facility Name
Klinikum Coburg GmbH
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR
City
Dresden
ZIP/Postal Code
01099
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe gGmbH
City
Karlsruhe
Country
Germany
Facility Name
Leipzig Heart Institute GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis am Park Sanssouci
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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

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