Trial Outcomes & Findings for Cardioband With Transfemoral Delivery System (NCT NCT01841554)
NCT ID: NCT01841554
Last Updated: 2020-11-30
Results Overview
Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
30 days
Results posted on
2020-11-30
Participant Flow
Of 62 patients originally enrolled, 1 excluded from full analysis data set (N=61) but included in safety analysis data set (N=62). Patient had severe MR, right heart failure (RHF), and tricuspid regurgitation (TR); determined to be a significant deviation from intended use of device. Study protocol amended to exclude severe RHF and TR.
Participant milestones
| Measure |
Single
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
Implanted
|
60
|
|
Overall Study
1 Year Follow Up
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Single
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
No Implantation
|
1
|
|
Overall Study
Discontinued Follow Up
|
5
|
|
Overall Study
Study exit due to secondary intervention
|
6
|
Baseline Characteristics
Data Unavailable for 2 patients.
Baseline characteristics by cohort
| Measure |
Single
n=61 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 7.5 • n=61 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=61 Participants
|
|
EuroSCORE II
|
7.3 Score
STANDARD_DEVIATION 6.3 • n=61 Participants
|
|
New York Heart Association (NYHA) Functional Class III or IV
|
52 Participants
n=61 Participants
|
|
Ischemic Etiology of Regurgitation
|
37 Participants
n=61 Participants
|
|
Left Ventricule Ejection Fraction (LVEF)
|
33 Percent Fraction
STANDARD_DEVIATION 11 • n=61 Participants
|
|
Previous Coronary Artery Bypass Graft (CABG)
|
18 Participants
n=59 Participants • Data Unavailable for 2 patients.
|
|
Renal Insufficiency
|
49 Participants
n=61 Participants
|
|
Atrial Fibrillation
|
46 Participants
n=60 Participants • Data unavailable for 1 patient.
|
PRIMARY outcome
Timeframe: 30 daysOverall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.
Outcome measures
| Measure |
Single
n=61 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Death
|
2 Participants
|
|
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Myocardial Infarction
|
1 Participants
|
|
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Major Bleeding Complications
|
2 Participants
|
|
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Renal Failure
|
4 Participants
|
|
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Cardiac Tamponade
|
1 Participants
|
|
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Respiratory Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 monthsPopulation: Intra-subject comparison of 18 patients who had data at all three time points (baseline, 6 and 12 months).
Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.
Outcome measures
| Measure |
Single
n=18 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Performance [6MWT]
6 Months
|
393.2222 Meters
Standard Deviation 114.4529
|
|
Performance [6MWT]
1 Year
|
407.0556 Meters
Standard Deviation 122.8899
|
|
Performance [6MWT]
Baseline
|
334.7778 Meters
Standard Deviation 120.3957
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 monthsPopulation: Intra-subject comparison of 27 patients who had data at all three time points (baseline, 6 and 12 months).
Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.
Outcome measures
| Measure |
Single
n=27 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Performance [MLHFQ]
Baseline
|
35.8889 Scores on a scale
Standard Deviation 16.6579
|
|
Performance [MLHFQ]
6 Months
|
16.2593 Scores on a scale
Standard Deviation 14.9244
|
|
Performance [MLHFQ]
1 Year
|
19.3333 Scores on a scale
Standard Deviation 19.9538
|
SECONDARY outcome
Timeframe: Baseline, discharge, 6 and 12 monthsPopulation: Intra-subject comparison of 26 patients who were assessed for MR grade across all four time points (baseline, discharge, 6 and 12 months).
All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Outcome measures
| Measure |
Single
n=26 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Performance [Intra-subject Comparison - MR Severity]
Baseline · Moderate - Severe (3-4+)
|
16 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
Baseline · Moderate (2+)
|
10 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
Baseline · Trace - Mild (0-1+)
|
0 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
Discharge · Moderate - Severe (3-4+)
|
1 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
Discharge · Moderate (2+)
|
5 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
Discharge · Trace - Mild (0-1+)
|
20 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
6 Months · Moderate - Severe (3-4+)
|
0 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
6 Months · Moderate (2+)
|
5 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
6 Months · Trace - Mild (0-1+)
|
21 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
1 Year · Moderate - Severe (3-4+)
|
0 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
1 Year · Moderate (2+)
|
7 Participants
|
|
Performance [Intra-subject Comparison - MR Severity]
1 Year · Trace - Mild (0-1+)
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline, discharge, 6 and 12 monthsPopulation: The outcome is reported where data is available.
All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Outcome measures
| Measure |
Single
n=61 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Performance [Full Analysis Data Set - MR Severity]
Baseline · Moderate - Severe (3-4+)
|
45 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
Baseline · Moderate (2+)
|
16 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
Baseline · Trace - Mild (0-1+)
|
0 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
Discharge · Moderate - Severe (3-4+)
|
6 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
Discharge · Moderate (2+)
|
13 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
Discharge · Trace - Mild (0-1+)
|
39 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
6 Months · Moderate (2+)
|
11 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
6 Months · Trace - Mild (0-1+)
|
29 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
1 Year · Moderate - Severe (3-4+)
|
2 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
1 Year · Moderate (2+)
|
10 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
1 Year · Trace - Mild (0-1+)
|
27 Participants
|
|
Performance [Full Analysis Data Set - MR Severity]
6 Months · Moderate - Severe (3-4+)
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-adjustment, discharge, and 30 DaysPopulation: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and post-adjustment, discharge, and 30 days is 47, 50 and 46, respectively.
Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1.
Outcome measures
| Measure |
Single
n=58 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Reduce MR [Paired Baseline and Follow-Up]
Post-Adjustment
|
47 Participants
|
|
Reduce MR [Paired Baseline and Follow-Up]
Discharge
|
50 Participants
|
|
Reduce MR [Paired Baseline and Follow-Up]
30 Days
|
46 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately after procedureThe ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire.
Outcome measures
| Measure |
Single
n=61 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Technical Feasibility of Cardioband Adjustment
|
58 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately after implantationThe ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System.
Outcome measures
| Measure |
Single
n=61 Participants
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Technical Success Rate of the Implantation of the Cardioband
|
60 Participants
|
Adverse Events
Single
Serious events: 44 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single
n=62 participants at risk
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Atrial Fibrillation
|
3.2%
2/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Atrial Septal Defect
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Bundle Branch Block Left
|
3.2%
2/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Cardiac Arrest
|
3.2%
2/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Cardiac Failure
|
24.2%
15/62 • Number of events 22 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Cardiac Tamponade
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Cardiogenic Shock
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Dyspnoea
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Left Ventricular Failure
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Mitral Valve Disease
|
6.5%
4/62 • Number of events 4 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Myocardial Infarction
|
3.2%
2/62 • Number of events 3 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Pericardial Effusion
|
4.8%
3/62 • Number of events 4 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Sick Sinus Syndrome
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Cardiac disorders
Ventricular Tachycardia
|
4.8%
3/62 • Number of events 3 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Eye disorders
Cataract
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Gastrointestinal disorders
Melaena
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
General disorders
Chest Pain
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
General disorders
Device Dislocation
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
General disorders
Multi-Organ Failure
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
General disorders
Oedema due to Cardiac Disease
|
3.2%
2/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Infections and infestations
Pneumonia
|
3.2%
2/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Infections and infestations
Sepsis
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Infections and infestations
Septic Shock
|
3.2%
2/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Infections and infestations
Staphylococcal Infection
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Infections and infestations
Urinary Tract Infection
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Injury, poisoning and procedural complications
Iatrogenic Injury
|
3.2%
2/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Investigations
Blood Glucose Increased
|
1.6%
1/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Investigations
Haemoglobin Decreased
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Investigations
Troponin Increased
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
1.6%
1/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Musculoskeletal and connective tissue disorders
Meniscus Injury
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of Eye
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Intestine Polyp
|
1.6%
1/62 • Number of events 2 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Nervous system disorders
Haemorrhagic Stroke
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Nervous system disorders
Hemiparesis
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Nervous system disorders
Ischaemic Stroke
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Nervous system disorders
Syncope
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Renal and urinary disorders
Renal Failure
|
6.5%
4/62 • Number of events 8 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Respiratory, thoracic and mediastinal disorders
Actinomycotic Pulmonary Infection
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Surgical and medical procedures
Cardiac Pacemaker Replacement
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Surgical and medical procedures
Hospitalisation
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Surgical and medical procedures
Implantable Defibrillator Insertion
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Vascular disorders
Air Embolism
|
4.8%
3/62 • Number of events 3 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Vascular disorders
Hypotension
|
1.6%
1/62 • Number of events 1 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
Other adverse events
| Measure |
Single
n=62 participants at risk
Multi-center, prospective study with intra-subject comparisons
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
9.7%
6/62 • Number of events 6 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
General disorders
Device Fastener Issue
|
6.5%
4/62 • Number of events 4 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
6.5%
4/62 • Number of events 4 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Investigations
Haemoglobin Decreased
|
6.5%
4/62 • Number of events 4 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
|
Renal and urinary disorders
Renal Failure
|
8.1%
5/62 • Number of events 5 • 1 Year
Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place