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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
Sponsor:
Information provided by (Responsible Party):
Rolf Franck Berntsen, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: FIRM ablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Atrial fibrillation
  • Rotors
  • Mapping
  • Radiofrequency ablation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Cumulative freedom from atrial fibrillation (AF) (multi-procedure). [ Time Frame: 30 months. ]
    Cumulative freedom from AF (multi-procedure) measured from final study.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Norway
Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Rolf Franck Berntsen, MD, PhD Dept. of Cardiology, Rikshospitalet - Oslo University Hospital

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Responsible Party: Rolf Franck Berntsen, M.D, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02101541     History of Changes
Other Study ID Numbers: 2013/627
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rolf Franck Berntsen, Oslo University Hospital:
Atrial fibrillation
Arrhythmias, Cardiac
Heart diseases
Cardiovascular diseases
Pathological processes

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes