Trial Outcomes & Findings for AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (NCT NCT00560885)
NCT ID: NCT00560885
Last Updated: 2013-03-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
55 participants
Primary outcome timeframe
6 Months Post Procedure
Results posted on
2013-03-29
Participant Flow
Treatment subjects were recruited from the routine clinical referral base of one or more surgeons at each investigational site.
Subjects were screened for enrollment and consented prior to being brought to the OR with the potential that they may not be eligible based on some criteria evaluated in OR (i.e. left atrial size assessed by TEE). 1 subject was found to have LA size that excluded them from the trial.
Participant milestones
| Measure |
AtriCure Bipolar System
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
30 Day Follow-up
|
53
|
|
Overall Study
3 Month Follow-up
|
51
|
|
Overall Study
6 Month Follow-up
|
50
|
|
Overall Study
12 Month Follow-up
|
48
|
|
Overall Study
2 Year Follow-up
|
47
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
AtriCure Bipolar System
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
AtriCure Bipolar System
n=55 Participants
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
|
Age Continuous
|
70.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 Months Post ProcedurePopulation: The analysis population included subjects that were evaluable for the Primary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.
Outcome measures
| Measure |
AtriCure Bipolar System
n=50 Participants
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
|
74 percentage of subjects
Interval 60.0 to 100.0
|
PRIMARY outcome
Timeframe: 30 days Post ProcedurePopulation: Safety was evaluated in all subjects enrolled and treated with the device.
Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.
Outcome measures
| Measure |
AtriCure Bipolar System
n=55 Participants
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
|
9.1 percentage of subjects
Interval 0.0 to 17.9
|
SECONDARY outcome
Timeframe: 6 Months Post ProcedurePopulation: The analysis population included subjects that were evaluable for the Secondary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.
Outcome measures
| Measure |
AtriCure Bipolar System
n=50 Participants
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
|
84 percentage of subjects
Interval 66.7 to 94.6
|
SECONDARY outcome
Timeframe: 6 Months Post ProcedurePopulation: Safety was evaluated in all subjects enrolled and treated with the device.
Outcome measures
| Measure |
AtriCure Bipolar System
n=55 Participants
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Composite 6-month Post-procedure Major Adverse Event Rate.
|
10.9 percentage of subjects
Interval 2.9 to 26.1
|
Adverse Events
AtriCure Bipolar System
Serious events: 45 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AtriCure Bipolar System
n=55 participants at risk
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Cardiac disorders
Mitral valve incompetence
|
3.6%
2/55 • Number of events 2 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
4/55 • Number of events 4 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Atrial flutter
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Atrial rupture
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Atrioventricular block
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Bradycardia
|
14.5%
8/55 • Number of events 8 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Cardiac failure congestive
|
20.0%
11/55 • Number of events 11 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Cardiac tamponade
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Cardiogenic shock
|
3.6%
2/55 • Number of events 2 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Nodal arrhythmia
|
3.6%
2/55 • Number of events 2 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Pericardial effusion
|
3.6%
2/55 • Number of events 2 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Sick sinus syndrome
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Sinus arrest
|
3.6%
2/55 • Number of events 2 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Sinus bradycardia
|
3.6%
2/55 • Number of events 2 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Gastrointestinal disorders
Ascites
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
General disorders
Multi-organ failure
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
General disorders
Sudden death
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Hepatobiliary disorders
Hepatic failure
|
1.8%
1/55 • Number of events 2 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Infections and infestations
Bacteraemia
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Infections and infestations
Breast abscess
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Infections and infestations
Pneumonia
|
7.3%
4/55 • Number of events 4 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Infections and infestations
Sepsis
|
3.6%
2/55 • Number of events 2 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Infections and infestations
Wound infection
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Injury, poisoning and procedural complications
Atrial rupture
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Injury, poisoning and procedural complications
Venous injury
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Injury, poisoning and procedural complications
Hyponatraemia
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Musculoskeletal and connective tissue disorders
Critical illness polyneuropathy
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Nervous system disorders
Carotid artery stenosis
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Nervous system disorders
Cerebrovascular accident
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Renal and urinary disorders
Renal failure
|
12.7%
7/55 • Number of events 7 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Renal and urinary disorders
Renal mass
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
18.2%
10/55 • Number of events 11 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.5%
3/55 • Number of events 3 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.4%
9/55 • Number of events 9 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Vascular disorders
Haemorrhage
|
21.8%
12/55 • Number of events 13 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Vascular disorders
Hypotension
|
1.8%
1/55 • Number of events 1 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
Other adverse events
| Measure |
AtriCure Bipolar System
n=55 participants at risk
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
|
|---|---|
|
Cardiac disorders
Bradycardia
|
25.5%
14/55 • Number of events 14 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Cardiac Failure Congestive
|
20.0%
11/55 • Number of events 12 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Nodal Arrhythmia
|
5.5%
3/55 • Number of events 3 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Cardiac disorders
Sinus bradycardia
|
9.1%
5/55 • Number of events 5 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Infections and infestations
Candidiasis
|
7.3%
4/55 • Number of events 4 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Infections and infestations
Pneumonia
|
10.9%
6/55 • Number of events 6 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Infections and infestations
Urinary Tract Infection
|
10.9%
6/55 • Number of events 6 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.4%
9/55 • Number of events 10 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Renal and urinary disorders
Renal Failure
|
14.5%
8/55 • Number of events 8 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
30.9%
17/55 • Number of events 21 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.5%
3/55 • Number of events 3 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
18.2%
10/55 • Number of events 10 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Vascular disorders
Haemorrhage
|
21.8%
12/55 • Number of events 13 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Vascular disorders
Hypotension
|
5.5%
3/55 • Number of events 3 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Blood and lymphatic system disorders
Coagulopathy
|
9.1%
5/55 • Number of events 5 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
|
Blood and lymphatic system disorders
Anaemia
|
32.7%
18/55 • Number of events 19 • Primary safety endpoint is rate of Major Adverse Events occuring at 30 days post procedure. Secondary safety endpoint is the composite 6 month post procedure Major Adverse Event rate. Adverse events were collected through 12 month follow up.
Major Adverse Events wre Death, Stroke, Transient Ischemic Attacks, Myocardial infarction and Excessive Bleeding
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor can review communications prior to public release and can embargo communication regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the tim submitted to the sponsor for review. The sponsor can redact or modify the proposed publication to remove any language the sponsor believes would be detrimental to intellectual property or inaccurately reflect the results of the study.
- Publication restrictions are in place
Restriction type: OTHER