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

NCT02274857 | Completed Results DMC

• 1 other identifier: REAFFIRM
• Study Type: interventional
• Target: 350
• Locations: 3 countries
• Sites: 18

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).

Conditions

Persistent Atrial Fibrillation

Keywords

Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap); Rotor; FIRM-guided procedure; REAFFIRM

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (2)

Standard PVI Ablation

ACTIVE COMPARATOR

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

Procedure: Standard PVI Ablation

FIRM-guided Procedure and PVI

EXPERIMENTAL

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

Procedure: FIRM-Guided Procedure and PVI

Interventions

Standard PVI Ablation PROCEDURE

Standard PVI procedure without FIRMap.

Also known as: Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation, Mapping

Standard PVI Ablation

FIRM-Guided Procedure and PVI PROCEDURE

FIRM-guided procedure followed by conventional ablation including PVI.

Also known as: Pulmonary vein isolation, Ablation, Arrhythmia, Persistent atrial fibrillation, Mapping, FIRMap

FIRM-guided Procedure and PVI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (18)

Arizona Heart Rhythm Center

Phoenix, Arizona, 85013, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Indiana University - Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46260, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Location

Hackensack UMC

Hackensack, New Jersey, United States

Location

Weill Medical College at Cornell University

New York, New York, 10065, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Location

Herz- und Diabeteszentrum Bad Oeynhausen

Bad Oeynhausen, Minden-Lübbecke, 32545, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Klinikum Coburg GmbH

Coburg, 96450, Germany

Location

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

Dresden, 01099, Germany

Location

Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Germany

Location

Leipzig Heart Institute GmbH

Leipzig, 04289, Germany

Location

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Potsdam, 14471, Germany

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Program Director
• Organization: Abbott

kristin.ruffner@abbott.com

651-756-6717

Study Officials

• Johannes Brachmann, MD

  Klinikum Coburg GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: October 1, 2014
• Primary Completion: November 10, 2018
• Study Completion: November 10, 2018
• Last Updated: February 7, 2020
• Results First Posted: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); NL (1); DE (7)