RADAR Clinical Trial

NCT03263702 | Completed Results DMC FDA Device

• 1 other identifier: GCO 17-1537
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent Atrial Fibrillation; mapping

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Rate of Post-ablation Inducibility of AF

  Day 1

• Duration of RF Ablation

  Day 1

• Duration of Fluoro Time

  Day 1

• Duration of Exposure

  Day 1

• Duration of Procedure Time

  Day 1

Study Arms (1)

Computational Mapping Algorithm

EXPERIMENTAL

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

Interventions

Computational Mapping Algorithm DEVICE

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).

Computational Mapping Algorithm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivek Reddy: lead
• AFTx, Inc.: collaborator

Study Sites (4)

University of Colorado Medical Center

Denver, Colorado, 80045, United States

Location

South Denver Cardiology

Denver, Colorado, 80120, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 31944826 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sam Cammack
• Organization: Icahn School of Medicine at Mount Sinai

sam.cammack@mountsinai.org

212-824-8931

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: August 28, 2017
• Study Start: June 26, 2017
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: May 13, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)