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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
FIRM ablation
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Arrhythmias, Cardiac, Heart diseases, Cardiovascular diseases, Pathological processes

Eligibility Criteria

21 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Cardiology, Rikshospitalet - Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FIRM ablation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 28, 2014
Last Updated
June 21, 2016
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02101541
Brief Title
FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
Official Title
Focal Impulse and Rotor Modulation (FIRM) as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Arrhythmias, Cardiac, Heart diseases, Cardiovascular diseases, Pathological processes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FIRM ablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
FIRM ablation
Other Intervention Name(s)
Atrial fibrillation, Rotors, Mapping, Radiofrequency ablation
Intervention Description
Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.
Primary Outcome Measure Information:
Title
Single procedure freedom from atrial fibrillation (AF) at 12 months.
Description
Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
Time Frame
12 months.
Secondary Outcome Measure Information:
Title
Single procedure freedom from atrial fibrillation (AF) at 24 months.
Description
Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
Time Frame
24 months.
Title
Single procedure freedom from atrial fibrillation (AF) at 30 months.
Description
Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
Time Frame
30 months.
Other Pre-specified Outcome Measures:
Title
Cumulative freedom from atrial fibrillation (AF) (multi-procedure).
Description
Cumulative freedom from AF (multi-procedure) measured from final study.
Time Frame
30 months.
Title
Major procedure related events.
Description
Cardiac tamponade/perforation; stroke; transient ischemic attack; bleeding; vascular access complications; injury to the esophagus/phrenic or vagal nerve etc.
Time Frame
0 to 12 months.
Title
Number of rotors identified and percentage eliminated on remap.
Description
Number of rotors identified and percentage eliminated on remap will be evaluated during the procedure.
Time Frame
Procedural.
Title
Quality of life (QOL).
Description
QOL will be evaluated by the SF-36 health survey (Norwegian version) pre- and 12 months post ablation.
Time Frame
12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Franck Berntsen, MD, PhD
Organizational Affiliation
Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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