RADAR Clinical Trial

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263702
• Other study ID #: GCO 17-1537
• Status: Completed
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: June 7, 2019

Study information

• Verified date: May 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	South Denver Cardiology	Denver	Colorado
United States	University of Colorado Medical Center	Denver	Colorado
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Vivek Reddy	AFTx, Inc

Country where clinical trial is conducted

United States, 

Outcome

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