Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIRM ablation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIRM ablation | Procedure | Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single procedure freedom from atrial fibrillation (AF) at 12 months. | Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor. | 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Single procedure freedom from atrial fibrillation (AF) at 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative freedom from atrial fibrillation (AF) (multi-procedure). | Cumulative freedom from AF (multi-procedure) measured from final study. | 30 months. |
| Major procedure related events. | Cardiac tamponade/perforation; stroke; transient ischemic attack; bleeding; vascular access complications; injury to the esophagus/phrenic or vagal nerve etc. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rolf Franck Berntsen, MD, PhD | Dept. of Cardiology, Rikshospitalet - Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Cardiology, Rikshospitalet - Oslo University Hospital | Oslo | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
| 30 months. |
| 0 to 12 months. |
| Number of rotors identified and percentage eliminated on remap. | Number of rotors identified and percentage eliminated on remap will be evaluated during the procedure. | Procedural. |
| Quality of life (QOL). | QOL will be evaluated by the SF-36 health survey (Norwegian version) pre- and 12 months post ablation. | 12 months. |