Clinical trial NCT03263702: RADAR Clinical Trial
Official title: Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Persistent Atrial Fibrillation
mapping
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: AFTx, Inc.
First posted: 2017-08-28
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Atrial Fibrillation Termination
timeFrame: Day 1
measure: Number of Participants Free From Recurrent AT/AF on no AAD
timeFrame: at 12 months
measure: Number of Participants Free From Recurrent AT/AF With no or Some AAD
timeFrame: at 12 months
Secondary outcomes:
measure: Rate of Post-ablation Inducibility of AF
timeFrame: Day 1
measure: Duration of RF Ablation
timeFrame: Day 1
measure: Duration of Fluoro Time
timeFrame: Day 1
measure: Duration of Exposure
timeFrame: Day 1
measure: Duration of Procedure Time
timeFrame: Day 1
measure: Number of Procedure-related Adverse Events
timeFrame: up to 12 months
measure: Number of Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
measure: Number of Serious Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Medical Center
state: Colorado
city: Denver
country: United States
facility: South Denver Cardiology
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.