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Completed

NCT Number: NCT03263702

RADAR Clinical Trial

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.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Denver Cardiology, Denver, Colorado, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Number of Participants With Atrial Fibrillation Termination

    Time frame: Day 1

    Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)

  2. Number of Participants Free From Recurrent AT/AF on no AAD

    Time frame: at 12 months

    Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)

  3. Number of Participants Free From Recurrent AT/AF With no or Some AAD

    Time frame: at 12 months

    Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs

Secondary outcomes

  1. Rate of Post-ablation Inducibility of AF

    Time frame: Day 1

    Post-ablation inducibility of AF (> 5 mins) with burst pacing

  2. Duration of RF Ablation

    Time frame: Day 1

    Amount of radiofrequency ablation used for atrial fibrillation ablation

  3. Duration of Fluoro Time

    Time frame: Day 1

    Duration of fluoroscopy used during the AF ablation procedure

  4. Duration of Exposure

    Time frame: Day 1

    Radiation exposure due to fluoroscopy during the AF ablation procedure

  5. Duration of Procedure Time

    Time frame: Day 1

    Duration of RADAR procedure time

  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

Sponsors and collaborators

Lead sponsor

Vivek Reddy

Other

Collaborators

  • AFTx, Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2017
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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