Trial Outcomes & Findings for RADAR Clinical Trial (NCT NCT03263702)
NCT ID: NCT03263702
Last Updated: 2020-05-13
Results Overview
Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Day 1
Results posted on
2020-05-13
Participant Flow
Participant milestones
| Measure |
De Novo
Participants with 1st procedure
|
Re-Do Ablation
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
26
|
|
Overall Study
COMPLETED
|
35
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
De Novo
Participants with 1st procedure
|
Re-Do Ablation
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
RADAR Clinical Trial
Baseline characteristics by cohort
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)
Outcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Number of Participants With Atrial Fibrillation Termination
|
23 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: at 12 monthsNumber of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)
Outcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Number of Participants Free From Recurrent AT/AF on no AAD
|
25 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: at 12 monthsNumber of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs
Outcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Number of Participants Free From Recurrent AT/AF With no or Some AAD
|
25 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day 1Post-ablation inducibility of AF (\> 5 mins) with burst pacing
Outcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Rate of Post-ablation Inducibility of AF
|
61 percent of occurences
|
46 percent of occurences
|
SECONDARY outcome
Timeframe: Day 1Amount of radiofrequency ablation used for atrial fibrillation ablation
Outcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Duration of RF Ablation
|
323 minutes
Standard Deviation 141.5
|
316 minutes
Standard Deviation 88.56
|
SECONDARY outcome
Timeframe: Day 1Duration of fluoroscopy used during the AF ablation procedure
Outcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Duration of Fluoro Time
|
25.5 minutes
Standard Deviation 13.1
|
24.1 minutes
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Day 1Radiation exposure due to fluoroscopy during the AF ablation procedure
Outcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Duration of Exposure
|
245 mGy
Standard Deviation 201
|
241 mGy
Standard Deviation 197
|
SECONDARY outcome
Timeframe: Day 1Duration of RADAR procedure time
Outcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Duration of Procedure Time
|
23.6 minutes
Standard Deviation 20.3
|
34.5 minutes
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: up to 12 monthsOutcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Number of Procedure-related Adverse Events
|
7 events
|
4 events
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Number of Major Adverse Cardiac Events (MACE)
|
1 events
|
1 events
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
De Novo
n=38 Participants
Participants with 1st procedure
|
Re-Do Ablation
n=26 Participants
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Number of Serious Adverse Events
|
12 events
|
8 events
|
Adverse Events
De Novo
Serious events: 10 serious events
Other events: 8 other events
Deaths: 0 deaths
Re-Do Ablation
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
De Novo
n=38 participants at risk
Participants with 1st procedure
|
Re-Do Ablation
n=26 participants at risk
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Nervous system disorders
Amiodarone induced ataxia
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
General disorders
Amiodarone Intolerance
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis with lower back abscess
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacebation
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Infections and infestations
Fever
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Gastrointestinal disorders
Gastroesophageal bleed with hypotension
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
General disorders
Generalized Weakness
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Cardiac disorders
Non-sustained Ventricular Tachycardia
|
5.3%
2/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Renal and urinary disorders
Prostatectomy
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Vascular disorders
Pseudoaneurysm of right femoral artery
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Cardiac disorders
Severe Mitral Valve Regurgitation, and Paroxysmal Atrial Fibrillation
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Cardiac disorders
Severe three vessel coronary artery disease
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
General disorders
Shortness of breath and abdominal rash
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Gastrointestinal disorders
Upper GI bleed
|
2.6%
1/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Cardiac disorders
Worsening heart failure with influenza
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
Other adverse events
| Measure |
De Novo
n=38 participants at risk
Participants with 1st procedure
|
Re-Do Ablation
n=26 participants at risk
Participants who need a re-do ablation procedure
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Nervous system disorders
Cogitive Decline
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Cardiac disorders
Congestive Heart Failure
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Cardiac disorders
Atypical flutter with RVR
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Infections and infestations
Fever
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Cardiac disorders
Fluid Overload
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Gastrointestinal disorders
Hematochezia
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Vascular disorders
Lower extremity edema
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Cardiac disorders
Peripheral Edema
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Infections and infestations
Pneumonia
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Cardiac disorders
Recurrent Left Pleural Effusions
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
Cardiac disorders
Symptomatic PVCs
|
2.6%
1/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Renal and urinary disorders
Vaginitis
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
|
General disorders
Vertigo (Labyrinthitis)
|
0.00%
0/38 • 12 months
|
3.8%
1/26 • 12 months
|
|
Cardiac disorders
VF with ICD Shock
|
2.6%
1/38 • 12 months
|
0.00%
0/26 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place