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RADAR Clinical Trial

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ClinicalTrials.gov Identifier: NCT03263702
Recruitment Status : Active, not recruiting
First Posted : August 28, 2017
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
AFTx, Inc
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: Computational Mapping Algorithm Not Applicable

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  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Rate of Atrial Fibrillation termination [ Time Frame: Day 1 ]
    Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into NSR or AT

  2. Number of Participants Free from recurrent AT/AF [ Time Frame: at 12 months ]
    Clinical Outcome Analysis - Freedom from recurrent AT/AF


Secondary Outcome Measures :
  1. Rate of post-ablation inducibility of AF [ Time Frame: Day 1 ]
    Post-ablation inducibility of AF (> 5 mins) with burst pacing

  2. Total duration of RF ablation [ Time Frame: Day 1 ]
  3. Total duration of Fluoro time [ Time Frame: Day 1 ]
  4. Total duration of exposure [ Time Frame: Day 1 ]
  5. Total duration of procedure time [ Time Frame: Day 1 ]
  6. Number of Procedure-related adverse events [ Time Frame: up to 12 months ]
  7. Number of Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]
  8. Number of Serious Adverse Events [ Time Frame: 12 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263702


Locations
United States, Colorado
University of Colorado Medical Center
Denver, Colorado, United States, 80045
South Denver Cardiology
Denver, Colorado, United States, 80120
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Texas
Seton Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Vivek Reddy
AFTx, Inc
Investigators
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Vivek Reddy, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03263702     History of Changes
Other Study ID Numbers: GCO 17-1873
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
Persistent Atrial Fibrillation
mapping

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes