RADAR Clinical Trial

Not Applicable

Completed

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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Computational Mapping Algorithm	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (4): University of Colorado Medical Center
🇺🇸
Denver, Colorado, United States
South Denver Cardiology
🇺🇸
Denver, Colorado, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States