NCT02101541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

February 28, 2014

Last Update Submit

June 21, 2016

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationArrhythmias, CardiacHeart diseasesCardiovascular diseasesPathological processes

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Single procedure freedom from atrial fibrillation (AF) at 24 months.

    24 months.

  • Single procedure freedom from atrial fibrillation (AF) at 30 months.

    30 months.

Other Outcomes (4)

  • Cumulative freedom from atrial fibrillation (AF) (multi-procedure).

    30 months.

  • Major procedure related events.

    0 to 12 months.

  • Number of rotors identified and percentage eliminated on remap.

    Procedural.

  • +1 more other outcomes

Study Arms (1)

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.

Procedure: FIRM ablation

Interventions

FIRM ablationPROCEDURE

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

Also known as: Atrial fibrillation, Rotors, Mapping, Radiofrequency ablation
FIRM ablation

Eligibility Criteria

Age21 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Cardiology, Rikshospitalet - Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic Processes

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Rolf Franck Berntsen, MD, PhD

    Dept. of Cardiology, Rikshospitalet - Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, PhD

Study Record Dates

First Submitted

February 28, 2014

First Posted

April 2, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)