Trial Outcomes & Findings for Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study (NCT NCT01246466)
NCT ID: NCT01246466
Last Updated: 2021-04-01
Results Overview
Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
Results posted on
2021-04-01
Participant Flow
Participants were recruited at 5 academic medical centers. The first participant was enrolled in December 2010 and the last participant was enrolled in October 2011.
Participant milestones
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Baseline characteristics by cohort
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
Height
|
70.5 inches
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Weight
|
214.7 pounds
STANDARD_DEVIATION 33.4 • n=5 Participants
|
|
BMI
|
30.4 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
Outcome measures
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Primary Safety Endpoint
MI per IPA
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
|
Primary Safety Endpoint
MI per FDA
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
|
Primary Safety Endpoint
Death per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Excessive bleeding per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Stroke per IPA
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
|
Primary Safety Endpoint
TIA per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Cardiac Tamponade per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Pulmonary Embolism per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Peripheral Embolism per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Atrio-esophageal Fistula per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Diaphragmatic Paralysis per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Pulmonary Vein Stenosis per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
New 2nd/3rd Degree AV Block Requiring PPM per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Serious Skin Burns per IPA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Conversion to Thoracotomy or Sternotomy per IPA
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
|
Primary Safety Endpoint
Catheter Related SAEs per IPA
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
|
Primary Safety Endpoint
Surgical Procedure Related SAEs per IPA
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
|
Primary Safety Endpoint
Death per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Excessive Bleeding per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Stroke per FDA
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
|
Primary Safety Endpoint
TIA per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Cardiac Tamponade per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Pulmonary Embolism per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Atrioesophageal Fistula per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Diaphragmatic Paralysis per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Pulmonary Vein Stenosis per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
New 2nd/3rd Degree AV Block Requiring PPM per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Serious Skin Burns per FDA
|
0 percentage of participants
Interval 0.0 to 14.2
|
|
Primary Safety Endpoint
Conversion to Thoracotomy or Sternotomy per FDA
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
|
Primary Safety Endpoint
Catheter Related SAEs per FDA
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
PRIMARY outcome
Timeframe: 12 month follow-upPopulation: Denominators (19) are subjects who are evaluable for primary efficacy endpoint.
Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.
Outcome measures
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=19 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Absence of Atrial Fibrillation
Success at 12 Months
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
|
Absence of Atrial Fibrillation
Failure by AAD
|
10.5 percentage of participants
Interval 1.3 to 33.1
|
|
Absence of Atrial Fibrillation
Failure by Holter/Pacemaker Interrogation
|
21.1 percentage of participants
Interval 6.1 to 45.6
|
|
Absence of Atrial Fibrillation
Atrial Fibrillation
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
|
Absence of Atrial Fibrillation
Atrial Flutter
|
0 percentage of participants
Interval 0.0 to 17.6
|
|
Absence of Atrial Fibrillation
Atrial Tachycardia
|
21.1 percentage of participants
Interval 6.1 to 45.6
|
|
Absence of Atrial Fibrillation
Failure by both AAD and Holter/Pacemaker Interrog
|
0.0 percentage of participants
Interval 0.0 to 17.6
|
SECONDARY outcome
Timeframe: 12 month follow-upOutcome measures
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Excessive Bleeding
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Stroke
|
1 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
TIA
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
MI
|
1 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Cardiac Tamponade
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Pulmonary Embolism
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Peripheral Embolism
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Atrio-esophageal Fistula
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Diaphragmatic Paralysis
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Pulmonary Vein Stenosis
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
New 2nd/3rd Degree AV Block Requiring PPM
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Serious Skin Burns
|
0 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Conversion to Thoracotomy or Sternotomy
|
2 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Catheter Related SAEs
|
2 Participants
|
|
Overall Serious Device or Procedure Related Adverse Event Rate
Surgical Procedure Related SAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: Upon completion of the index procedure, up to ten hoursOutcome measures
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Acute Procedure Success
Inferior Right Pulmonary Veins Isolation Evaluated
|
100 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Inferior Right Pulmonary Veins Isolation Achieved
|
100 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Inferior Left Pulmonary Veins Isolation Evaluated
|
100 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Inferior Left Pulmonary Veins Isolation Achieved
|
95.8 percentage of participants
Interval 78.9 to 99.9
|
|
Acute Procedure Success
Superior Right Pulmonary Veins Isolation Evaluated
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Superior Right Pulmonary Veins Isolation Achieved
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Superior Left Pulmonary Veins Isolation Evaluated
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Superior Left Pulmonary Veins Isolation Achieved
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Left Atrium Posterior Box Isolation Evaluated
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Left Atrium Posterior Box Isolation Achieved
|
54.2 percentage of participants
Interval 32.8 to 74.4
|
|
Acute Procedure Success
Bi-drectional block Mitral Valve Isthmus Evaluated
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Bi-drectional block Mitral Valve Isthmus Achieved
|
83.3 percentage of participants
Interval 62.6 to 95.3
|
|
Acute Procedure Success
Bi-directional block of RC isthmus evaluated
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Bi-directional block of RC isthmus achieved
|
83.3 percentage of participants
Interval 62.6 to 95.3
|
|
Acute Procedure Success
Superior Vena Cava block evaluated
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Acute Procedure Success
Superior Vena Cava block achieved
|
87.5 percentage of participants
Interval 67.6 to 97.3
|
SECONDARY outcome
Timeframe: After the 3 month blanking period through twelve month follow-up.Population: Denominators are subjects who are evaluable for secondary efficacy endpoint.
Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.
Outcome measures
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Absence of Atrial Fibrillation
Efficacy Evaluable at 6 months
|
22 Participants
|
|
Absence of Atrial Fibrillation
Free of AF independent of the need for AADs at 6M
|
20 Participants
|
|
Absence of Atrial Fibrillation
Efficacy Evaluable at 12 Months
|
19 Participants
|
|
Absence of Atrial Fibrillation
Free of AF independent of the need for AADs at 12M
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 monthsNumber of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months
Outcome measures
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Number of Participants With Reintervention to Address Atrial Dysrhythmia
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Denominators are subjects who are evaluable for secondary efficacy endpoint.
Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0)
Outcome measures
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Improvement in AF
Change in AF Symptom Checklist Frequency Score
|
13.4 units on a scale
Standard Deviation 8.4
|
|
Improvement in AF
Change in AF Symptom Checklist Severity Score
|
9.8 units on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: During index procedurePopulation: Denominators are subjects who are evaluable for secondary efficacy endpoint.
Outcome measures
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 Participants
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Duration of Procedure
Total Surgery Time
|
8.9 Hours
Standard Deviation 1.2
|
|
Duration of Procedure
Epicardial Surgical Procedure Time
|
3.9 Hours
Standard Deviation 0.9
|
|
Duration of Procedure
EP Catheter Procedure Time
|
2.9 Hours
Standard Deviation 1.1
|
Adverse Events
AtriCure Bipolar System Combined With a Catheter Ablation
Serious events: 16 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 participants at risk
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Nervous system disorders
Embolic Stroke
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Cardiac Perforation
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Atrial Flutter
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Infection
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Wound Infection
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Embolic Stroke - Epicardial Ablation Procedure
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Vocal Cord Paresis
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Neuropathy Peripheral
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Renal and urinary disorders
Renal Failure
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Effusion
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Atrial Fibrillation - Other Relationship
|
8.3%
2/24 • Number of events 2 • Treatment to 24 months
|
|
Cardiac disorders
Atrial Flutter - Other Relationship
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Bradycardia
|
12.5%
3/24 • Number of events 3 • Treatment to 24 months
|
|
Cardiac disorders
Ventricular Fibrillation - Other Relationship
|
4.2%
1/24 • Number of events 2 • Treatment to 24 months
|
|
Eye disorders
Visual Impairment
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
General disorders
Non-Cardiac Chest Pain
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Cellulitis
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Urinary Tract Infection
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Injury, poisoning and procedural complications
Implantable Defribrillator Malfunction
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Presyncope
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Vascular disorders
Ischaemia
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
Other adverse events
| Measure |
AtriCure Bipolar System Combined With a Catheter Ablation
n=24 participants at risk
Procedure using the AtriCure Bipolar System plus a catheter ablation
Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation
|
|---|---|
|
Nervous system disorders
Embolic Stroke
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Atrial Flutter
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Cardiac Perforation
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Infection
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Wound Infection
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Injury, poisoning and procedural complications
Cardiac Vein Perforation
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Embolic Stroke - Epicardial Ablation Procedure
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Vocal Cord Paresis
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
3/24 • Number of events 3 • Treatment to 24 months
|
|
Cardiac disorders
Pericarditis
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Gastrointestinal disorders
Mouth Ulceration
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Neuropathy Peripheral
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Renal and urinary disorders
Renal Failure
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Renal and urinary disorders
Urinary Retention
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Effusion
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Blood and lymphatic system disorders
Anaemia - Other Relationship
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Atrial Fibrillation
|
8.3%
2/24 • Number of events 2 • Treatment to 24 months
|
|
Cardiac disorders
Atrial Flutter - Other Relationship
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Atrioventricular Block
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Bradycardia
|
12.5%
3/24 • Number of events 4 • Treatment to 24 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Cardiac disorders
Ventricular Fibrillation
|
4.2%
1/24 • Number of events 2 • Treatment to 24 months
|
|
Endocrine disorders
Hypothyroidism
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Eye disorders
Visual Impairment
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
General disorders
Chest Pains
|
8.3%
2/24 • Number of events 3 • Treatment to 24 months
|
|
General disorders
Non-Cardiac Chest Pain
|
4.2%
1/24 • Number of events 2 • Treatment to 24 months
|
|
General disorders
Oedema Peripheral
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Cellulitis
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Pneumonia
|
8.3%
2/24 • Number of events 2 • Treatment to 24 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
4/24 • Number of events 4 • Treatment to 24 months
|
|
Injury, poisoning and procedural complications
Implantable Defribillator Malfunction
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Injury, poisoning and procedural complications
Ulnar Nerve Injury
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Metabolism and nutrition disorders
Gout
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Essential Tremor
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
2/24 • Number of events 2 • Treatment to 24 months
|
|
Nervous system disorders
Presyncope
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Nervous system disorders
Syncope
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Vascular disorders
Hypertension
|
12.5%
3/24 • Number of events 3 • Treatment to 24 months
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
|
Vascular disorders
Ischaemia
|
4.2%
1/24 • Number of events 1 • Treatment to 24 months
|
Additional Information
Vice President, Clinical Affairs and Biometrics
AtriCure
Phone: 1-513-644-8192
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place