FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation

June 21, 2016 updated by: Rolf Franck Berntsen, Oslo University Hospital

Focal Impulse and Rotor Modulation (FIRM) as a Stand-alone Procedure in the Treatment of Atrial Fibrillation

The FIRM Study Oslo will in two sequential within-patient trials investigate the efficacy of focal impulse and rotor modulation (FIRM) as a stand-alone procedure in the treatment of paroxysmal and persistent atrial fibrillation, evaluated by continuous pre- and post-procedural heart rhythm monitoring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After a pilot/implementation study consisting of 10 patients with paroxysmal atrial fibrillation (AF); 20 patients with paroxysmal AF will be included in a within-patient trial. This study will be followed by a similar comparison in 20 patients with persistent or longstanding persistent AF.

The AF driving sources will be visualized by a novel sequential bi-atrial panoramic contact mapping technique. Unipolar signals will be recorded by a 64-polar basket catheter (FIRMap®, Topera. Inc.), then processed and the activation patterns visualized (RhythmView® 3D Electrophysiologic Mapping System, Topera, Inc.).

Focal impulse and rotor modulation (FIRM) will then be performed with standard irrigated radio frequency catheter ablation until rotor or focal impulse elimination is confirmed by repeat FIRM mapping.

Treatment efficacy will be assessed with continuous heart rhythm monitors (Reveal XT®, Medtronic, Minneapolis, USA) implanted 3 months prior to ablation, and freedom from AF defined as AF burden <1% at follow-up at 12, 24 and 30 months.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Dept. of Cardiology, Rikshospitalet - Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Paroxysmal atrial fibrillation despite of at least one Class I or Class III antiarrhythmic drug and/or previous conventional ablation (pulmonary vein isolation).
  • At least one episode of paroxysmal atrial fibrillation should be documented by rhythm strip, ECG or implanted monitor during the last 6 months prior to ablation.

Exclusion Criteria:

  • Significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation).
  • Intracardiac thrombus, tumor or dense contrast on TEE.
  • Contraindication to anticoagulant therapy (heparin, warfarin, dabigatran and rivaroxaban).
  • Anaphylactic allergy to contrast media.
  • Poor general health resulting from other disease.
  • Inability or refusal to provide written informed consent for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIRM ablation

The first part of this within-patient trial investigate the efficacy of focal impulse and rotor modulation in 20 patients with paroxysmal atrial fibrillation, evaluated by continuous pre- and post-procedural heart rhythm monitoring.

The second part consists of 20 patients with persistent or longstanding persistent atrial fibrillation following the same scheme.
Procedure: FIRM ablation
Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.
Other Names:
  • Radiofrequency ablation
  • Mapping
  • Rotors
  • Atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single procedure freedom from atrial fibrillation (AF) at 12 months.
Time Frame: 12 months.
Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single procedure freedom from atrial fibrillation (AF) at 24 months.
Time Frame: 24 months.
Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
24 months.
Single procedure freedom from atrial fibrillation (AF) at 30 months.
Time Frame: 30 months.
Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
30 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative freedom from atrial fibrillation (AF) (multi-procedure).
Time Frame: 30 months.
Cumulative freedom from AF (multi-procedure) measured from final study.
30 months.
Major procedure related events.
Time Frame: 0 to 12 months.
Cardiac tamponade/perforation; stroke; transient ischemic attack; bleeding; vascular access complications; injury to the esophagus/phrenic or vagal nerve etc.
0 to 12 months.
Number of rotors identified and percentage eliminated on remap.
Time Frame: Procedural.
Number of rotors identified and percentage eliminated on remap will be evaluated during the procedure.
Procedural.
Quality of life (QOL).
Time Frame: 12 months.
QOL will be evaluated by the SF-36 health survey (Norwegian version) pre- and 12 months post ablation.
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Rolf Franck Berntsen, MD, PhD, Dept. of Cardiology, Rikshospitalet - Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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