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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Oslo, Norge
- Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Single procedure freedom from atrial fibrillation (AF) at 12 months.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Single procedure freedom from atrial fibrillation (AF) at 24 months.
Tidsram: 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.
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cumulative freedom from atrial fibrillation (AF) (multi-procedure).
Tidsram: 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.
Tidsram: 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.
Tidsram: 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).
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Rolf Franck Berntsen, MD, PhD, Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2013/627
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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