Persistent Atrial FibrillationNCT03263702
RADAR Clinical Trial
A study testing Computational Mapping Algorithm in people with Persistent Atrial Fibrillation, run by Vivek Reddy at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Computational Mapping Algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Jun 2017to 7 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Colorado Medical Center
Denver, Colorado, 80045
South Denver Cardiology
Denver, Colorado, 80120
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
Read the 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).
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Computational Mapping Algorithm
- Keywords
- Persistent Atrial Fibrillation, mapping
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computational Mapping AlgorithmDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Computational Mapping Algorithm | Experimental | 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. Receives: Device: Computational Mapping Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
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)
Measured: at 12 months
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
Measured: at 12 months
Secondary outcomes (8)
Rate of Post-ablation Inducibility of AF
Post-ablation inducibility of AF (> 5 mins) with burst pacing
Measured: Day 1
Duration of RF Ablation
Amount of radiofrequency ablation used for atrial fibrillation ablation
Measured: Day 1
Duration of Fluoro Time
Duration of fluoroscopy used during the AF ablation procedure
Measured: Day 1
Duration of Exposure
Radiation exposure due to fluoroscopy during the AF ablation procedure
Measured: Day 1
Duration of Procedure Time
Duration of RADAR procedure time
Measured: Day 1
Number of Procedure-related Adverse Events
Measured: up to 12 months
Number of Major Adverse Cardiac Events (MACE)
Measured: 12 months
Number of Serious Adverse Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start26 Jun 2017
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Collaborators
- AFTx, Inc.
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263702
- Sponsor's protocol ID
- GCO 17-1537
- Status last verified
- May 2020
- First submitted
- 28 Jun 2017
- Last updated
- 13 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31944826
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)
- ClinicalTrials.gov ID
- NCT03263702
- Acronym / sponsor ID
- GCO 17-1537
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Persistent Atrial Fibrillation, mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Collaborators
- AFTx, Inc.
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Posted 21 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computational Mapping Algorithm | Experimental | Device: Computational Mapping AlgorithmAF 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computational Mapping AlgorithmThis 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). | Device | Computational Mapping Algorithm |
Primary outcome
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)
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)
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
8 secondary outcomes
Rate of Post-ablation Inducibility of AF
Time frame: Day 1
Duration of RF Ablation
Time frame: Day 1
Duration of Fluoro Time
Time frame: Day 1
Duration of Exposure
Time frame: Day 1
Duration of Procedure Time
Time frame: Day 1
Number of Procedure-related Adverse Events
Time frame: up to 12 months
Number of Major Adverse Cardiac Events (MACE)
Time frame: 12 months
Number of Serious Adverse Events
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31944826Choudry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computational Mapping Algorithm in people with Persistent Atrial Fibrillation, run by Vivek Reddy at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Atrial Fibrillation Termination (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.