FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT02101541|
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : June 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: FIRM ablation||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Focal Impulse and Rotor Modulation (FIRM) as a Stand-alone Procedure in the Treatment of Atrial Fibrillation|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||June 2016|
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.
- 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.
- 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.
- 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.
- Cumulative freedom from atrial fibrillation (AF) (multi-procedure). [ Time Frame: 30 months. ]Cumulative freedom from AF (multi-procedure) measured from final study.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101541
|Dept. of Cardiology, Rikshospitalet - Oslo University Hospital|
|Principal Investigator:||Rolf Franck Berntsen, MD, PhD||Dept. of Cardiology, Rikshospitalet - Oslo University Hospital|