Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)

NCT01925885 | Terminated DMC

• 1 other identifier: IU-1302010649
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

• Hypothesis: Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or eliminate clinical atrial fibrillation in subjects with accepted indications for catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation.
• Summary: This is a prospective randomized study to assess the safety and effectiveness of FIRM procedures only, versus standard Pulmonary Vein Isolation (PVI) procedures for the treatment of symptomatic paroxysmal atrial fibrillation.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Acute Ablation Success for Paroxysmal Atrial Fibrillation

  * the termination of spontaneous or induced atrial fibrillation by ablation at an atrial fibrillation source arrhythmia location * the slowing of the mean atrial fibrillation rate at least by 10% by ablation at an atrial fibrillation source arrhythmia * evaluate safety and effectiveness of the FIRM procedures for the treatment of paroxysmal atrial fibrillation * freedom from major adverse events related to the procedure within 7 days of the procedure

  1 week

Secondary Outcomes (1)

• Long Term Ablation Success for Paroxysmal Atrial Fibrillation

  1 year

Other Outcomes (1)

• Quality of Life

  1 year

Study Arms (2)

PVI Ablation

ACTIVE COMPARATOR

Standard of care arm-pulmonary vein isolation (PVI)-involving moving the ablation catheter from point to point in a continuous line to surround the the orifices of the pulmonary veins in order to eliminate electrical conduction between the veins and left atrium.

Procedure: PVI Ablation

FIRM Ablation

EXPERIMENTAL

FIRM ablation for paroxysmal atrial fibrillation at sites of rotors or focal impulse formation as designated by using the mapping algorithm of RhythmView

Procedure: FIRM Ablation

Interventions

PVI Ablation PROCEDURE

PVI ablation for atrial fibrillation specifically targets areas in the left atrium in the area just outside the pulmonary veins to eliminate triggers of atrial fibrillation.

Also known as: Ablation, Atrial Fibrillation, Arrhythmia, Radiofrequency Ablation, Mapping, Pulmonary Veins, Paroxysmal Atrial Fibrillation

PVI Ablation

FIRM Ablation PROCEDURE

Ablation for atrial fibrillation specifically targets areas in the left or right atrium to eliminate areas that maintain atrial fibrillation without isolating the pulmonary veins

Also known as: Ablation, Atrial Fibrillation, Arrhythmia, Radiofrequency Ablation, Mapping, Rotors, Pulmonary Veins, Paroxysmal Atrial Fibrillation

FIRM Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reported incidence of at least two (2) documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the six months preceding trial entry (at least one episode should be documented by rhythm strip or ECG).
• Attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping the medication (drug duration and dose will be documented).
• Left atrial size \<55mm in largest dimension (typically atrial septum to carina of left pulmonary veins) as measured and image documented by preoperative imaging (CT or MRI)
• Anticoagulation therapy-Oral anticoagulation required (in the case of Warfarin, therapeutic International Normalized Ratio (INR) for at least three weeks prior to randomization) for those subjects who meet two or more of the following criteria:
• Age 65 years or older
• Diabetes
• Prior stroke or transient ischemic attack
• Congestive heart failure
• Hypertension with systolic\>165 mm Hg
• Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the procedure)
• Sustained AF-if the patient is not experiencing spontaneous, sustained AF (\>10 min uninterrupted), sustained AF may be induced by burst atrial pacing with or without isoproterenol infusion in conventional clinical fashion.

You may not qualify if:

• Previous catheter or surgical left atrial ablation
• Structural heart disease of clinical significance including
• Congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation
• Myocardial infarction (MI) within the past three (3) months
• Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study
• Atrial Septal Defect closure device; Left Atrial Appendage closure device; prosthetic mitral or tricuspid valve
• Anaphylactic allergy to contrast media
• Atrial fibrillation secondary to electrolyte imbalance
• thyroid disease
• reversible non-cardiac cause
• Poor general health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
• Reversible cause of atrial fibrillation (e.g. surgery, hyperthyroidism, pericarditis)
• Contraindication to heparin and warfarin/other new oral anticoagulants (e.g. dabigatran, rivaroxaban, apixaban \[when available\])
• History of pulmonary embolus within one year of enrollment
• Acute pulmonary edema

Sponsors & Collaborators

• Indiana University: lead
• University of California, Los Angeles: collaborator
• Topera, Medical: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• John M Miller, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 20, 2013
• Study Start: September 1, 2013
• Primary Completion: December 23, 2015
• Study Completion: December 23, 2015
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

US (1)