FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Focal Impulse and Rotor Modulation (FIRM) as a Stand-alone Procedure in the Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101541
• Other study ID #: 2013/627
• Status: Completed
• Phase: N/A
• First received: February 28, 2014
• Last updated: June 21, 2016
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 74 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• FIRM ablation
Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.

Locations

Country	Name	City	State
Norway	Dept. of Cardiology, Rikshospitalet - Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative freedom from atrial fibrillation (AF) (multi-procedure).	Cumulative freedom from AF (multi-procedure) measured from final study.	30 months.	No
Other	Major procedure related events.	Cardiac tamponade/perforation; stroke; transient ischemic attack; bleeding; vascular access complications; injury to the esophagus/phrenic or vagal nerve etc.	0 to 12 months.	No
Other	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.	No
Other	Quality of life (QOL).	QOL will be evaluated by the SF-36 health survey (Norwegian version) pre- and 12 months post ablation.	12 months.	No
Primary	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.	No
Secondary	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.	No
Secondary	Single procedure freedom from atrial fibrillation (AF) at 30 months.	Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.	30 months.	No