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

• 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.

Study Overview

• Status: Terminated
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: PVI Ablation; Procedure: FIRM Ablation

Detailed Description

A total of 188 subjects will be enrolled-subjects will be equally (1:1) randomized between those undergoing conventional atrial fibrillation ablation with confirmation of pulmonary vein isolation (PVI) versus those actively treated with the FIRM procedure without PVI.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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:

  1. Age 65 years or older
  2. Diabetes
  3. Prior stroke or transient ischemic attack
  4. Congestive heart failure
  5. 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.

Exclusion Criteria:

• 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

  1. thyroid disease
  2. 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
• Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 72 hours of the procedure if deemed appropriate by the investigator
• Any history of a cerebrovascular disease-including stroke or Transient Ischemic Attack
• Any anticipation of cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
• History of documented thromboembolic event within the past one year
• Diagnosed atrial myxoma
• Significant pulmonary disease
• Acute illness or active systemic infection or sepsis
• Any history of blood clotting abnormalities or bleeding tendencies unrelated to supratherapeutic anticoagulation
• Life expectancy <365 days (12 months)
• Any intracardiac thrombus, tumor. or other abnormality that precludes safe catheter introduction or manipulation
• Continuous AF episode lasting >7 days immediately prior to the procedure without any sinus rhythm
• Patients who have previously undergone cardioversion are excluded from participation in the study unless there is documentation that cardioversion has been performed within 72 hours of episode onset
• Amiodarone use in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PVI Ablation; 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; 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.; Other Names: Paroxysmal Atrial Fibrillation; Ablation; Atrial Fibrillation; Arrhythmia; Radiofrequency Ablation; Mapping; Pulmonary Veins
Experimental: FIRM Ablation; 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; 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; Other Names: Paroxysmal Atrial Fibrillation; Ablation; Atrial Fibrillation; Arrhythmia; Radiofrequency Ablation; Mapping; Pulmonary Veins; Rotors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Ablation Success for Paroxysmal Atrial Fibrillation	freedom from atrial fibrillation recurrence (>30sec) from 3-12 months; freedom from major adverse events related to the procedure within one year of the procedure	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	EuroQOL Eq-5D scores pre-ablation will be compared to those post ablation at all points separately and together	1 year

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: University of California, Los Angeles; Topera, Medical
• Investigators: Principal Investigator: John M Miller, MD, Indiana University

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 23, 2015
• Study Completion (Actual): December 23, 2015

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 16, 2013
• First Posted (Estimate): August 20, 2013

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Atrial Arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IU-1302010649