NCT03263702

RADAR Clinical Trial

Completed NA Results posted Last updated 13 May 2020

What this trial tests

NA trial testing Computational Mapping Algorithm in Persistent Atrial Fibrillation in 65 participants. Completed in 7 June 2019.

Timeline

26 June 2017

Primary endpoint
7 June 2019

7 June 2019

Quick facts

Lead sponsor	Vivek Reddy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	65
Start date	26 June 2017
Primary completion	7 June 2019
Estimated completion	7 June 2019
Sites	4 locations across United States

Drugs / interventions tested

• Computational Mapping Algorithm

Conditions studied

• Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →

Sponsor

Vivek Reddy

Who can join

19 and older, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Atrial Fibrillation Termination Primary · Day 1

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

Group	Value	95% CI
De Novo	23
Re-Do Ablation	12

Number of Participants Free From Recurrent AT/AF on no AAD Primary · at 12 months

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

Group	Value	95% CI
De Novo	25
Re-Do Ablation	13

Number of Participants Free From Recurrent AT/AF With no or Some AAD Primary · at 12 months

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

Group	Value	95% CI
De Novo	25
Re-Do Ablation	17

Rate of Post-ablation Inducibility of AF Secondary · Day 1

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

Group	Value	95% CI
De Novo	61
Re-Do Ablation	46

Duration of RF Ablation Secondary · Day 1

Amount of radiofrequency ablation used for atrial fibrillation ablation

Group	Value	95% CI
De Novo	323	± 141.5
Re-Do Ablation	316	± 88.56

Duration of Fluoro Time Secondary · Day 1

Duration of fluoroscopy used during the AF ablation procedure

Group	Value	95% CI
De Novo	25.5	± 13.1
Re-Do Ablation	24.1	± 9.0

Duration of Exposure Secondary · Day 1

Radiation exposure due to fluoroscopy during the AF ablation procedure

Group	Value	95% CI
De Novo	245	± 201
Re-Do Ablation	241	± 197

Duration of Procedure Time Secondary · Day 1

Duration of RADAR procedure time

Group	Value	95% CI
De Novo	23.6	± 20.3
Re-Do Ablation	34.5	± 19.3

Number of Procedure-related Adverse Events Secondary · up to 12 months

Group	Value	95% CI
De Novo	7
Re-Do Ablation	4

Number of Major Adverse Cardiac Events (MACE) Secondary · 12 months

Group	Value	95% CI
De Novo	1
Re-Do Ablation	1

Number of Serious Adverse Events Secondary · 12 months

Group	Value	95% CI
De Novo	12
Re-Do Ablation	8

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

De Novo

Serious: 10/38 (26%)

Deaths: 0/38

Re-Do Ablation

Serious: 5/26 (19%)

Deaths: 0/26

Serious adverse events (18 terms)

Reaction	System	De Novo	Re-Do Ablation
Non-sustained Ventricular Tachycardia	Cardiac disorders	—	—
Amiodarone induced ataxia	Nervous system disorders	—	—
Amiodarone Intolerance	General disorders	—	—
Blood in stool	Gastrointestinal disorders	—	—
Bronchitis	Respiratory, thoracic and mediastinal disorders	—	—
Cellulitis with lower back abscess	Skin and subcutaneous tissue disorders	—	—
COPD Exacebation	Respiratory, thoracic and mediastinal disorders	—	—
Fever	Infections and infestations	—	—
Gastroesophageal bleed with hypotension	Gastrointestinal disorders	—	—
Generalized Weakness	General disorders	—	—
Hematuria	Renal and urinary disorders	—	—
Prostatectomy	Renal and urinary disorders	—	—
Pseudoaneurysm of right femoral artery	Vascular disorders	—	—
Severe Mitral Valve Regurgitation, and Paroxysmal Atrial Fibrillation	Cardiac disorders	—	—
Severe three vessel coronary artery disease	Cardiac disorders	—	—
Shortness of breath and abdominal rash	General disorders	—	—
Upper GI bleed	Gastrointestinal disorders	—	—
Worsening heart failure with influenza	Cardiac disorders	—	—

Other adverse events (16 terms — click to expand)

Reaction	System	De Novo	Re-Do Ablation
Chest pain	Cardiac disorders	—	—
Cogitive Decline	Nervous system disorders	—	—
Congestive Heart Failure	Cardiac disorders	—	—
Atypical flutter with RVR	Cardiac disorders	—	—
Fever	Infections and infestations	—	—
Fluid Overload	Cardiac disorders	—	—
Hematochezia	Gastrointestinal disorders	—	—
Lower extremity edema	Vascular disorders	—	—
Pericarditis	Cardiac disorders	—	—
Peripheral Edema	Cardiac disorders	—	—
Pneumonia	Infections and infestations	—	—
Recurrent Left Pleural Effusions	Cardiac disorders	—	—
Symptomatic PVCs	Cardiac disorders	—	—
Vaginitis	Renal and urinary disorders	—	—
Vertigo (Labyrinthitis)	General disorders	—	—
VF with ICD Shock	Cardiac disorders	—	—

Most-reported serious reactions: Non-sustained Ventricular Tachycardia, Amiodarone induced ataxia, Amiodarone Intolerance, Blood in stool, Bronchitis, Cellulitis with lower back abscess, COPD Exacebation, Fever.

Data from ClinicalTrials.gov NCT03263702 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. RADAR: A Multicenter Food and Drug Administration Investigational Device Exemption Clinical Trial of Persistent Atrial Fibrillation.
   Choudry S, Mansour M, Sundaram S, Nguyen DT, et al · · 2020 · cited 29× · PMID 31944826 · DOI 10.1161/circep.119.007825