Trial Outcomes & Findings for AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery (NCT NCT00779857)
NCT ID: NCT00779857
Last Updated: 2013-06-04
Results Overview
The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Discharge/30 days Post Procedure
Results posted on
2013-06-04
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).
Participant milestones
| Measure |
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
30 Day Post Procedure
|
68
|
|
Overall Study
3 Month Post Procedure
|
65
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Missed Visit
|
2
|
Baseline Characteristics
AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Baseline characteristics by cohort
| Measure |
AtriCure LAA Exclusion System
n=70 Participants
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants
|
|
Age Continuous
|
73.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Discharge/30 days Post ProcedurePopulation: The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.
The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.
Outcome measures
| Measure |
AtriCure LAA Exclusion System
n=70 Participants
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
|
|---|---|
|
Rate of Device Related Serious Adverse Events
|
0 Number of participants
Interval 0.0 to 0.0001
|
PRIMARY outcome
Timeframe: 3 Months Post ProcedurePopulation: The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.
The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.
Outcome measures
| Measure |
AtriCure LAA Exclusion System
n=61 Participants
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
|
|---|---|
|
Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
|
95.1 percentage of subjects
Interval 88.0 to 100.0
|
Adverse Events
AtriCure LAA Exclusion System
Serious events: 35 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AtriCure LAA Exclusion System
n=70 participants at risk
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/70 • Number of events 2 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Blood and lymphatic system disorders
Heparin-Induced Thrombocytopenia
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.9%
2/70 • Number of events 3 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Atrial Flutter
|
2.9%
2/70 • Number of events 2 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Atrioventricular Block
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
10.0%
7/70 • Number of events 7 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Bradycardia
|
4.3%
3/70 • Number of events 3 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.7%
4/70 • Number of events 5 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Low Cardiac Output Syndrome
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Sinoatrial Block
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Ventricular Fibrillation
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Ventricular Septal Defect Acquired
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
General disorders
General Physical Health Deterioration
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
General disorders
Oedema
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Infections and infestations
Bacteriaemia
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Infections and infestations
Incision Site Infection
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Injury, poisoning and procedural complications
Drug Administration Error
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
4.3%
3/70 • Number of events 3 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
5.7%
4/70 • Number of events 4 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Injury, poisoning and procedural complications
Toxic Encephalopathy
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Injury, poisoning and procedural complications
Traumatic Lung Injury
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Investigations
Ejection Fraction Decreased
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Nervous system disorders
Phrenic Nerve Paralysis
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Nervous system disorders
Syncope
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Psychiatric disorders
Mental Status Changes
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Renal and urinary disorders
Renal Failure
|
5.7%
4/70 • Number of events 5 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.9%
2/70 • Number of events 2 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
8.6%
6/70 • Number of events 7 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
8.6%
6/70 • Number of events 6 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Vascular disorders
Aortic Dissection
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.4%
1/70 • Number of events 1 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Vascular disorders
Haemorrhage
|
5.7%
4/70 • Number of events 4 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Vascular disorders
Hypotension
|
2.9%
2/70 • Number of events 2 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
Other adverse events
| Measure |
AtriCure LAA Exclusion System
n=70 participants at risk
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
45.7%
32/70 • Number of events 32 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Atrial Fibrillation
|
40.0%
28/70 • Number of events 30 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
10.0%
7/70 • Number of events 7 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Bradycardia
|
15.7%
11/70 • Number of events 11 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.7%
4/70 • Number of events 5 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Infections and infestations
Urinary Tract Infection
|
12.9%
9/70 • Number of events 9 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
10/70 • Number of events 10 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Renal and urinary disorders
Renal Failure
|
10.0%
7/70 • Number of events 8 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
15.7%
11/70 • Number of events 15 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
8.6%
6/70 • Number of events 6 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Vascular disorders
Haemorrhage
|
5.7%
4/70 • Number of events 4 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Vascular disorders
Hypotension
|
7.1%
5/70 • Number of events 5 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
5.7%
4/70 • Number of events 4 • Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
|
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