RADAR Clinical Trial

May 11, 2020 updated by: Vivek Reddy

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Medical Center
      • Denver, Colorado, United States, 80120
        • South Denver Cardiology
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Day 1
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)
at 12 months
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
at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Serious Adverse Events
Time Frame: 12 months
12 months
Rate of Post-ablation Inducibility of AF
Time Frame: Day 1
Post-ablation inducibility of AF (> 5 mins) with burst pacing
Day 1
Duration of RF Ablation
Time Frame: Day 1
Amount of radiofrequency ablation used for atrial fibrillation ablation
Day 1
Duration of Fluoro Time
Time Frame: Day 1
Duration of fluoroscopy used during the AF ablation procedure
Day 1
Duration of Exposure
Time Frame: Day 1
Radiation exposure due to fluoroscopy during the AF ablation procedure
Day 1
Duration of Procedure Time
Time Frame: Day 1
Duration of RADAR procedure time
Day 1
Number of Procedure-related Adverse Events
Time Frame: up to 12 months
up to 12 months
Number of Major Adverse Cardiac Events (MACE)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vivek Reddy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AFTx, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 17-1537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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