RADAR Clinical Trial

Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)

This prospective, multicenter, observational study will examine the ability of real time electrogram processing mapping to identify driver domains to target for ablation in persistent AF patients.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Computational Mapping Algorithm

Detailed Description

ABSTRACT: Recent clinical trials have shown that targeting rotors and focal impulses (FIs) during atrial fibrillation (AF) ablation improves outcomes. This study evaluated whether a novel computational mapping algorithm (CMA) could identify FIs and rotors, and characterize rotors when incidental ablation resulted in rhythm changes. Three-dimensional (3D) left atrial electroanatomic maps were created from signals recorded from multipolar circular mapping catheters in 61 patients undergoing persistent AF ablation. Forty of 61acquired patient datasets were of adequate quality for analysis CMA, employing an AF pattern recognition algorithm, creating 3D panoramic AF maps identifying drivers of AF (FI and rotors) post procedure. Rotors were further classified as substrate (SBR) or non-substrate based (NSBR) on the basis of rotor stability, proximity to voltage transition zones and complex fractionated atrial electrograms (CFAEs). Incidentally ablated identified AF drivers, including SBRs and NSBRs, were evaluated for rhythm changes. A total of 172 drivers were identified in 40 patients (2.2 drivers/patient). Seventy percent were rotors (120/172) and 30% were FIs (52/172). Sixty-seven percent of rotors were classified as SBR vs 33% as NSBR. Incidental ablation of SBRs resulted in rhythm change 91% of the time versus only 24% of the time for NSBR (p<0.0001).

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Medical Center
    • Denver, Colorado, United States, 80120
      • South Denver Cardiology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 18 years of age.
• Patients are considered eligible if they have symptomatic or drug-refractory AF and are planned to undergo a catheter ablation procedure for persistent AF (ether a first procedure or a redo procedure)
• Ability to understand the requirements of the study and sign the informed consent form.
• Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
• Projected lifespan greater than 1 year.

Exclusion Criteria:

• They have long-standing persistent AF prior to the first procedure (defined as AF greater than one year's duration).
• Rheumatic heart disease
• Current intra-cardiac thrombus
• History of MI or Coronary Artery Bypass Grafting (CABG) within 6 weeks
• Unstable angina
• CVA or TIA within 3 months
• Contraindication to anticoagulation
• Class IV HF
• Unable to sign consent
• Projected lifespan of < 1 year
• Women known to be pregnant or to have positive beta-HCG (Human Chorionic Gonadotropin).
• Participation in another study that would interfere with this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Computational Mapping Algorithm; AF mapping (utilizing CMA) will be performed and used to point the operator to regions within a heart chamber that should be interrogated further for suspicious electrogram activity, as measured by the St. Jude Ensite System, and ablated if the suspicious electrogram activity persists.

Device: Computational Mapping Algorithm; This software enables high resolution temporospatial mapping of atria for the identification of drivers of AF. CMA receives data from standard of care, commercially available 3D Mapping Systems (St. Jude Ensite System) and catheters and processes the data in a unique way. Electrogram and anatomy data are fed from the commercially available 3D Mapping System to an adjacent laptop computer, via an Ethernet connection, that is running CMA. CMA then processes the electrogram data and generates a map of where the potential AF driver domains are located and superimposes those potential AF driver domain targets onto the 3D geometry of the anatomy (provided by the 3D mapping system).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Atrial Fibrillation Termination	Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)	Day 1
Number of Participants Free From Recurrent AT/AF on no AAD	Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)	at 12 months
Number of Participants Free From Recurrent AT/AF With no or Some AAD	Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs	at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Serious Adverse Events		12 months
Rate of Post-ablation Inducibility of AF	Post-ablation inducibility of AF (> 5 mins) with burst pacing	Day 1
Duration of RF Ablation	Amount of radiofrequency ablation used for atrial fibrillation ablation	Day 1
Duration of Fluoro Time	Duration of fluoroscopy used during the AF ablation procedure	Day 1
Duration of Exposure	Radiation exposure due to fluoroscopy during the AF ablation procedure	Day 1
Duration of Procedure Time	Duration of RADAR procedure time	Day 1
Number of Procedure-related Adverse Events		up to 12 months
Number of Major Adverse Cardiac Events (MACE)		12 months

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Collaborators: AFTx, Inc

Publications and helpful links

General Publications

• Choudry S, Mansour M, Sundaram S, Nguyen DT, Dukkipati SR, Whang W, Kessman P, Reddy VY. RADAR: A Multicenter Food and Drug Administration Investigational Device Exemption Clinical Trial of Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2020 Jan;13(1):e007825. doi: 10.1161/CIRCEP.119.007825. Epub 2020 Jan 16.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Actual): June 7, 2019
• Study Completion (Actual): June 7, 2019

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Persistent Atrial Fibrillation; mapping
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: GCO 17-1537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes