FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
Focal Impulse and Rotor Modulation (FIRM) as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oslo, Norway
- Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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. |
Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Single procedure freedom from atrial fibrillation (AF) at 12 months.
Time Frame: 12 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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12 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Single procedure freedom from atrial fibrillation (AF) at 24 months.
Time Frame: 24 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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24 months.
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Single procedure freedom from atrial fibrillation (AF) at 30 months.
Time Frame: 30 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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30 months.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cumulative freedom from atrial fibrillation (AF) (multi-procedure).
Time Frame: 30 months.
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Cumulative freedom from AF (multi-procedure) measured from final study.
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30 months.
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Major procedure related events.
Time Frame: 0 to 12 months.
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Cardiac tamponade/perforation; stroke; transient ischemic attack; bleeding; vascular access complications; injury to the esophagus/phrenic or vagal nerve etc.
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0 to 12 months.
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Number of rotors identified and percentage eliminated on remap.
Time Frame: Procedural.
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Number of rotors identified and percentage eliminated on remap will be evaluated during the procedure.
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Procedural.
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Quality of life (QOL).
Time Frame: 12 months.
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QOL will be evaluated by the SF-36 health survey (Norwegian version) pre- and 12 months post ablation.
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12 months.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rolf Franck Berntsen, MD, PhD, Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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