Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Arrhythmias, Cardiac, Heart diseases, Cardiovascular diseases, Pathological processes
Brief summary
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.
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.
Interventions
PROCEDUREFIRM ablation
Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.
Sponsors
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single procedure freedom from atrial fibrillation (AF) at 12 months. | 12 months. | Freedom from AF defined as \<1% AF burden as detected by the implanted heart rhythm monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single procedure freedom from atrial fibrillation (AF) at 24 months. | 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. | 30 months. | Freedom from AF defined as \<1% AF burden as detected by the implanted heart rhythm monitor. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative freedom from atrial fibrillation (AF) (multi-procedure). | 30 months. | Cumulative freedom from AF (multi-procedure) measured from final study. |
| Quality of life (QOL). | 12 months. | QOL will be evaluated by the SF-36 health survey (Norwegian version) pre- and 12 months post ablation. |
| Major procedure related events. | 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. | Procedural. | Number of rotors identified and percentage eliminated on remap will be evaluated during the procedure. |
Countries
Norway
Outcome results
None listed