Trial Outcomes & Findings for TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System (NCT NCT02981953)
NCT ID: NCT02981953
Last Updated: 2021-06-28
Results Overview
Overall rate of Major Serious Adverse Events (MSAEs)\* and serious adverse device effects (SADE)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
30 days
Results posted on
2021-06-28
Participant Flow
Participant milestones
| Measure |
Cardioband Tricuspid Procedure
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Cardioband Tricuspid Procedure
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Overall Study
Death
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Withdrawal to non-compliance
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Age, Continuous
|
76.6 years
STANDARD_DEVIATION 6.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=40 Participants
|
|
Calculated BMI
|
25.0 kg/m^2
STANDARD_DEVIATION 3.9 • n=40 Participants
|
|
STS Score
|
2.8 Percentage of expected mortality
STANDARD_DEVIATION 1.5 • n=40 Participants
|
|
EUROSCORE II
|
4.4 Score
STANDARD_DEVIATION 2.9 • n=40 Participants
|
|
NYHA Class
II
|
6 Participants
n=40 Participants
|
|
NYHA Class
III
|
32 Participants
n=40 Participants
|
|
NYHA Class
IV
|
2 Participants
n=40 Participants
|
|
NYHA Class Grouped
I/II
|
6 Participants
n=40 Participants
|
|
NYHA Class Grouped
III/IV
|
34 Participants
n=40 Participants
|
|
Left Ventricle Ejection Franction (LVEF) %
|
56.9 Percent Fraction
STANDARD_DEVIATION 10.2 • n=38 Participants • The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.
|
|
FTR Etiology
Ischemic
|
7 Participants
n=40 Participants
|
|
FTR Etiology
Non-ischemic
|
33 Participants
n=40 Participants
|
|
Valve Surgery
Mitral Valve
|
4 Participants
n=40 Participants
|
|
Valve Surgery
Aortic Valve
|
1 Participants
n=40 Participants
|
|
Valve Surgery
Mitral and Aortic Valve
|
1 Participants
n=40 Participants
|
|
Valve Surgery
Other
|
0 Participants
n=40 Participants
|
|
Percutaneous Transcatheter Valve Replace/Repair other than Tricuspid
Transcatheter Aortic Valve Implantation
|
0 Participants
n=40 Participants
|
|
Percutaneous Transcatheter Valve Replace/Repair other than Tricuspid
Mitraclip
|
4 Participants
n=40 Participants
|
|
Percutaneous Transcatheter Valve Replace/Repair other than Tricuspid
Other
|
0 Participants
n=40 Participants
|
|
CABG
Single
|
3 Participants
n=40 Participants
|
|
CABG
Double
|
3 Participants
n=40 Participants
|
|
CABG
Triple/Quadruple/Quintuple
|
2 Participants
n=40 Participants
|
|
Percutaneous Coronary Intervention
|
8 Participants
n=40 Participants
|
|
Any Cardiac Device without Electrodes
Parachute Implant
|
0 Participants
n=40 Participants
|
|
Any Cardiac Device without Electrodes
LAA Closure
|
2 Participants
n=40 Participants
|
|
Any Cardiac Device without Electrodes
PFO Closure
|
1 Participants
n=40 Participants
|
|
Any Cardiac Device with Electrodes
Single Chamber Pacemaker Implant
|
1 Participants
n=40 Participants
|
|
Any Cardiac Device with Electrodes
Dual Chamber Pacemaker Implant
|
3 Participants
n=40 Participants
|
|
Any Cardiac Device with Electrodes
CRT Implant
|
0 Participants
n=40 Participants
|
|
Any Cardiac Device with Electrodes
ICD Implant
|
2 Participants
n=40 Participants
|
|
Any Cardiac Device with Electrodes
CRT-D Implant
|
1 Participants
n=40 Participants
|
|
Coronary Artery Disease
|
17 Participants
n=40 Participants
|
|
Previous MI
|
2 Participants
n=40 Participants
|
|
Angina Pectoris
|
0 Participants
n=40 Participants
|
|
Congestive Heart Failure
|
25 Participants
n=40 Participants
|
|
Aortic Valve
Moderate Regurgitation
|
0 Participants
n=40 Participants
|
|
Aortic Valve
Severe Regurgitation
|
0 Participants
n=40 Participants
|
|
Aortic Valve
Moderate Stenosis
|
0 Participants
n=40 Participants
|
|
Aortic Valve
Severe Stenosis
|
0 Participants
n=40 Participants
|
|
Aortic Valve
None
|
40 Participants
n=40 Participants
|
|
Mitral Valve
Moderate Regurgitation
|
0 Participants
n=40 Participants
|
|
Mitral Valve
Severe Regurgitation
|
0 Participants
n=40 Participants
|
|
Mitral Valve
Moderate Stenosis
|
0 Participants
n=40 Participants
|
|
Mitral Valve
Severe Stenosis
|
0 Participants
n=40 Participants
|
|
Mitral Valve
None
|
40 Participants
n=40 Participants
|
|
Pulmonic Valve
Moderate Regurgitation
|
0 Participants
n=40 Participants
|
|
Pulmonic Valve
Severe Regurgitation
|
0 Participants
n=40 Participants
|
|
Pulmonic Valve
Moderate Stenosis
|
0 Participants
n=40 Participants
|
|
Pulmonic Valve
Severe Stenosis
|
0 Participants
n=40 Participants
|
|
Pulmonic Valve
None
|
40 Participants
n=40 Participants
|
|
Atrial Flutter/Fibrillation
None
|
3 Participants
n=40 Participants
|
|
Atrial Flutter/Fibrillation
Paroxysmal
|
5 Participants
n=40 Participants
|
|
Atrial Flutter/Fibrillation
Persistant
|
20 Participants
n=40 Participants
|
|
Atrial Flutter/Fibrillation
Chronic
|
12 Participants
n=40 Participants
|
|
Flutter/Fibrillation Ablation
|
8 Participants
n=40 Participants
|
|
Ventricular Tachyarrhthmia
None
|
38 Participants
n=40 Participants
|
|
Ventricular Tachyarrhthmia
Sustained
|
1 Participants
n=40 Participants
|
|
Ventricular Tachyarrhthmia
Non-sustained
|
0 Participants
n=40 Participants
|
|
Ventricular Tachyarrhthmia
VF
|
1 Participants
n=40 Participants
|
|
Diabetes
|
10 Participants
n=40 Participants
|
|
Dyslipidemia
|
22 Participants
n=40 Participants
|
|
Systemic Hypertension
|
33 Participants
n=40 Participants
|
|
Peripheral Vascular Disease
|
7 Participants
n=40 Participants
|
|
Peripheral Vascular Intervention
|
0 Participants
n=40 Participants
|
|
Chronic Lung Disease (Moderate to Severe)
|
11 Participants
n=40 Participants
|
|
Chronic Renal Disease
|
22 Participants
n=40 Participants
|
|
Chronic Liver Disease
None/Mild
|
40 Participants
n=40 Participants
|
|
Chronic Liver Disease
Moderate
|
0 Participants
n=40 Participants
|
|
Chronic Liver Disease
Severe
|
0 Participants
n=40 Participants
|
|
Chronic Anemia
|
5 Participants
n=40 Participants
|
|
Estimated Glomerular Filtration (eGFR)
|
46.3 mL/min/1.73m^2
STANDARD_DEVIATION 17.6 • n=40 Participants
|
|
History of Endocarditis
|
1 Participants
n=40 Participants
|
|
Thyreosis
Hyperthyreosis
|
0 Participants
n=40 Participants
|
|
Thyreosis
Hypothyreosis
|
12 Participants
n=40 Participants
|
|
Ongoing Inotropic Support
|
0 Participants
n=40 Participants
|
|
Elevated Pulmonary Pressure (> 35mmHG)
|
19 Participants
n=40 Participants
|
|
Pulmonary Pressure
|
36.5 mmHg
STANDARD_DEVIATION 11.5 • n=37 Participants • The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.
|
|
Frailty Score
Very Fit (1)
|
0 Participants
n=40 Participants
|
|
Frailty Score
Well (2)/Well with Treated Comorbid Disease (3)
|
14 Participants
n=40 Participants
|
|
Frailty Score
Apparently Vulnerable (4)
|
6 Participants
n=40 Participants
|
|
Frailty Score
Mildly Frail (5)/Moderately Frail (6)
|
20 Participants
n=40 Participants
|
|
Frailty Score
Severely Frail (7)
|
0 Participants
n=40 Participants
|
|
Prior Stroke
|
4 Participants
n=40 Participants
|
|
Prior Transient Ischemic Attack
|
2 Participants
n=40 Participants
|
|
Carotid Surgery
|
1 Participants
n=40 Participants
|
|
Carotid Intervention
|
0 Participants
n=40 Participants
|
|
History of Smoking
None
|
26 Participants
n=40 Participants
|
|
History of Smoking
Current
|
3 Participants
n=40 Participants
|
|
History of Smoking
Past
|
11 Participants
n=40 Participants
|
|
Active Malignancy
|
0 Participants
n=40 Participants
|
|
Other Relevant Medical Conditions
|
32 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 30 daysOverall rate of Major Serious Adverse Events (MSAEs)\* and serious adverse device effects (SADE)
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
MSAE
|
3 Participants
|
|
Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
SADE
|
1 Participants
|
PRIMARY outcome
Timeframe: Intra-procedureSuccessful access, deployment and positioning of the Cardioband device
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Access, Deployment and Positioning of the Cardioband Device
|
39 Participants
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 monthsPopulation: Data was not collected
Successful access, deployment and positioning of the Cardioband device and septolateral reduction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: 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, 1 month, 30 days, 6 months, 12 months, and 24 months is 37, 33, 37, and 20 respectively. The outcome is reported where data is available.
Data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, and Severe. Data analysis per core lab.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=37 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (24 Months) · Severe
|
20 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (1 Month) · None
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (1 Month) · Mild
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (1 Month) · Moderate
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (1 Month) · Severe
|
37 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
1 Month · None
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
1 Month · Mild
|
5 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
1 Month · Moderate
|
11 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
1 Month · Severe
|
21 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (6 Months) · None
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (6 Months) · Mild
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (6 Months) · Moderate
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (6 Months) · Severe
|
33 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
6 Months · None
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
6 Months · Mild
|
3 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
6 Months · Moderate
|
10 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
6 Months · Severe
|
20 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (12 Months) · None
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (12 Months) · Mild
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (12 Months) · Moderate
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (12 Months) · Severe
|
27 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
12 Months · None
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
12 Months · Mild
|
2 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
12 Months · Moderate
|
9 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
12 Months · Severe
|
16 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (24 Months) · None
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (24 Months) · Mild
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Baseline (24 Months) · Moderate
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
24 Months · None
|
0 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
24 Months · Mild
|
8 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
24 Months · Moderate
|
7 Participants
|
|
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
24 Months · Severe
|
5 Participants
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, Severe. Data analysis per core lab.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Tricuspid Regurgitation [Full Analysis Data Set]
Baseline · None
|
0 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
Baseline · Mild
|
0 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
Baseline · Moderate
|
0 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
Baseline · Severe
|
40 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
1 Month · None
|
0 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
1 Month · Mild
|
5 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
1 Month · Moderate
|
11 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
1 Month · Severe
|
21 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
6 Months · None
|
0 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
6 Months · Mild
|
3 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
6 Months · Moderate
|
10 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
6 Months · Severe
|
20 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
12 Months · None
|
0 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
12 Months · Mild
|
2 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
12 Months · Moderate
|
9 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
12 Months · Severe
|
16 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
24 Months · None
|
0 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
24 Months · Mild
|
8 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
24 Months · Moderate
|
7 Participants
|
|
Tricuspid Regurgitation [Full Analysis Data Set]
24 Months · Severe
|
5 Participants
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: 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 1 month, 6 months, 12 months, and 24 months is 28, 21, 18, and 12 respectively. The outcome is reported where data is available.
Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=38 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
Baseline (1 Month)
|
0.8 cm^2
Standard Deviation 0.5
|
|
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
1 Month
|
0.6 cm^2
Standard Deviation 0.6
|
|
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
Baseline (6 Months)
|
0.8 cm^2
Standard Deviation 0.5
|
|
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
6 Months
|
0.4 cm^2
Standard Deviation 0.3
|
|
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
Baseline (12 Months)
|
0.8 cm^2
Standard Deviation 0.5
|
|
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
12 Months
|
0.4 cm^2
Standard Deviation 0.2
|
|
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
Baseline (24 Months)
|
0.3 cm^2
Standard Deviation 0.2
|
|
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
24 Months
|
-0.6 cm^2
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All data available for Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
24 Months
|
0.3 cm^2
Standard Deviation 0.2
|
|
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
Baseline
|
0.8 cm^2
Standard Deviation 0.5
|
|
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
1 Month
|
0.6 cm^2
Standard Deviation 0.6
|
|
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
6 Months
|
0.4 cm^2
Standard Deviation 0.3
|
|
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
12 Months
|
0.4 cm^2
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: 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 1 month, 6 months, 12 months, and 24 months is 11, 12, 3, and 4 respectively.
Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=38 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Regurgitant Volume [Paired Baseline and Follow-Up]
Baseline (1 Month)
|
97.1 ml
Standard Deviation 35.6
|
|
Regurgitant Volume [Paired Baseline and Follow-Up]
1 Month
|
70.7 ml
Standard Deviation 50.5
|
|
Regurgitant Volume [Paired Baseline and Follow-Up]
Baseline (6 Months)
|
104.2 ml
Standard Deviation 33.5
|
|
Regurgitant Volume [Paired Baseline and Follow-Up]
6 Months
|
76.9 ml
Standard Deviation 51.5
|
|
Regurgitant Volume [Paired Baseline and Follow-Up]
Baseline (12 Months)
|
76.5 ml
Standard Deviation 32.2
|
|
Regurgitant Volume [Paired Baseline and Follow-Up]
12 Months
|
51.2 ml
Standard Deviation 16.9
|
|
Regurgitant Volume [Paired Baseline and Follow-Up]
Baseline (24 Months)
|
98.1 ml
Standard Deviation 41.5
|
|
Regurgitant Volume [Paired Baseline and Follow-Up]
24 Months
|
47.2 ml
Standard Deviation 35.3
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Regurgitant Volume [Full Analysis Data Set]
Baseline
|
104.4 ml
Standard Deviation 37.0
|
|
Regurgitant Volume [Full Analysis Data Set]
1 Month
|
86.7 ml
Standard Deviation 51.7
|
|
Regurgitant Volume [Full Analysis Data Set]
6 Months
|
78.4 ml
Standard Deviation 43.2
|
|
Regurgitant Volume [Full Analysis Data Set]
12 Months
|
79.4 ml
Standard Deviation 35.4
|
|
Regurgitant Volume [Full Analysis Data Set]
24 Months
|
56.7 ml
Standard Deviation 37.3
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: 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, 1 month, 6 months, 12 months, and 24 months is 28, 26, 24, and 17 respectively.
Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=38 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
TAPSE [Paired Baseline and Follow-Up]
Baseline (30 Days)
|
1.4 cm
Standard Deviation 0.4
|
|
TAPSE [Paired Baseline and Follow-Up]
30 Days
|
1.3 cm
Standard Deviation 0.4
|
|
TAPSE [Paired Baseline and Follow-Up]
Baseline (6 Months)
|
1.4 cm
Standard Deviation 0.4
|
|
TAPSE [Paired Baseline and Follow-Up]
6 Months
|
1.4 cm
Standard Deviation 0.3
|
|
TAPSE [Paired Baseline and Follow-Up]
Baseline (12 Months)
|
1.4 cm
Standard Deviation 0.3
|
|
TAPSE [Paired Baseline and Follow-Up]
12 Months
|
1.3 cm
Standard Deviation 0.3
|
|
TAPSE [Paired Baseline and Follow-Up]
Baseline (24 Months)
|
1.4 cm
Standard Deviation 0.4
|
|
TAPSE [Paired Baseline and Follow-Up]
24 Months
|
1.3 cm
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All data for Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analyses based on core lab assessment.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
TAPSE [Full Analysis Data Set]
6 Months
|
1.4 cm
Standard Deviation 0.4
|
|
TAPSE [Full Analysis Data Set]
Baseline
|
1.5 cm
Standard Deviation 0.3
|
|
TAPSE [Full Analysis Data Set]
30 Days
|
1.4 cm
Standard Deviation 0.4
|
|
TAPSE [Full Analysis Data Set]
12 Months
|
1.3 cm
Standard Deviation 0.3
|
|
TAPSE [Full Analysis Data Set]
24 Months
|
1.4 cm
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: 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, 1 month, 6 months, 12 months, and 24 months is 37, 35, 30, and 25 respectively.
NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=37 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (1 Month) · II
|
6 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (6 Months) · I
|
0 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
12 Months · IV
|
1 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (24 Months) · II
|
5 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (24 Months) · III
|
20 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (1 Month) · I
|
0 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (1 Month) · III
|
30 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (1 Month) · IV
|
1 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
1 Month · I
|
5 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
1 Month · II
|
22 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
1 Month · III
|
10 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
1 Month · IV
|
0 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (6 Months) · II
|
6 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (6 Months) · III
|
28 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (6 Months) · IV
|
1 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
6 Months · I
|
8 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
6 Months · II
|
19 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
6 Months · III
|
8 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
6 Months · IV
|
0 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (12 Months) · I
|
0 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (12 Months) · II
|
6 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (12 Months) · III
|
23 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (12 Months) · IV
|
1 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
12 Months · I
|
10 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
12 Months · II
|
12 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
12 Months · III
|
7 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (24 Months) · I
|
0 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
Baseline (24 Months) · IV
|
0 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
24 Months · I
|
6 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
24 Months · II
|
12 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
24 Months · III
|
7 Participants
|
|
NYHA [Paired Baseline and Follow-Up]
24 Months · IV
|
0 Participants
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All data available for NYHA classification at 1 month, 6 months, 12 months, and 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
NYHA [Full Analysis Data Set]
6 Months · I
|
8 Participants
|
|
NYHA [Full Analysis Data Set]
6 Months · II
|
19 Participants
|
|
NYHA [Full Analysis Data Set]
6 Months · IV
|
0 Participants
|
|
NYHA [Full Analysis Data Set]
12 Months · III
|
7 Participants
|
|
NYHA [Full Analysis Data Set]
12 Months · IV
|
1 Participants
|
|
NYHA [Full Analysis Data Set]
24 Months · I
|
6 Participants
|
|
NYHA [Full Analysis Data Set]
24 Months · III
|
7 Participants
|
|
NYHA [Full Analysis Data Set]
24 Months · IV
|
0 Participants
|
|
NYHA [Full Analysis Data Set]
Baseline · I
|
0 Participants
|
|
NYHA [Full Analysis Data Set]
Baseline · II
|
6 Participants
|
|
NYHA [Full Analysis Data Set]
Baseline · III
|
32 Participants
|
|
NYHA [Full Analysis Data Set]
Baseline · IV
|
2 Participants
|
|
NYHA [Full Analysis Data Set]
1 Month · I
|
5 Participants
|
|
NYHA [Full Analysis Data Set]
1 Month · II
|
22 Participants
|
|
NYHA [Full Analysis Data Set]
1 Month · III
|
10 Participants
|
|
NYHA [Full Analysis Data Set]
1 Month · IV
|
0 Participants
|
|
NYHA [Full Analysis Data Set]
6 Months · III
|
8 Participants
|
|
NYHA [Full Analysis Data Set]
12 Months · I
|
10 Participants
|
|
NYHA [Full Analysis Data Set]
12 Months · II
|
12 Participants
|
|
NYHA [Full Analysis Data Set]
24 Months · II
|
12 Participants
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: 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 1 month, 6 months, 12 months, and 24 months is 29, 28, 25, and 17 respectively.
Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=29 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
6MWT [Paired Baseline and Follow-Up]
Baseline (1 Month)
|
232.0 Meters
Standard Deviation 117.5
|
|
6MWT [Paired Baseline and Follow-Up]
1 Month
|
289.4 Meters
Standard Deviation 118.7
|
|
6MWT [Paired Baseline and Follow-Up]
Baseline (6 Months)
|
236.1 Meters
Standard Deviation 107.8
|
|
6MWT [Paired Baseline and Follow-Up]
6 Months
|
280.6 Meters
Standard Deviation 132.8
|
|
6MWT [Paired Baseline and Follow-Up]
Baseline (12 Months)
|
222.2 Meters
Standard Deviation 104.7
|
|
6MWT [Paired Baseline and Follow-Up]
12 Months
|
273.6 Meters
Standard Deviation 133.4
|
|
6MWT [Paired Baseline and Follow-Up]
Baseline (24 Months)
|
211.6 Meters
Standard Deviation 124.9
|
|
6MWT [Paired Baseline and Follow-Up]
24 Months
|
294.3 Meters
Standard Deviation 121.0
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=36 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
6MWT [Full Analysis Data Set]
Baseline
|
221.9 Meters
Standard Deviation 113.0
|
|
6MWT [Full Analysis Data Set]
1 Month
|
289.4 Meters
Standard Deviation 118.7
|
|
6MWT [Full Analysis Data Set]
6 Months
|
279.2 Meters
Standard Deviation 130.6
|
|
6MWT [Full Analysis Data Set]
12 Months
|
273.6 Meters
Standard Deviation 133.4
|
|
6MWT [Full Analysis Data Set]
24 Months
|
288.2 Meters
Standard Deviation 120.2
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: 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 1 month, 6 months, 12 months, and 24 months is 37, 35, 31, and 28 respectively.
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=37 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
1 Month
|
56.7 Score
Standard Deviation 24.0
|
|
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
Baseline (6 Months)
|
44.6 Score
Standard Deviation 21.1
|
|
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
Baseline (1 Month)
|
44.4 Score
Standard Deviation 21.8
|
|
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
6 Months
|
63.6 Score
Standard Deviation 23.8
|
|
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
Baseline (12 Months)
|
43.3 Score
Standard Deviation 21.6
|
|
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
12 Months
|
59.6 Score
Standard Deviation 22.7
|
|
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
Baseline (24 Months)
|
47.0 Score
Standard Deviation 20.9
|
|
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
24 Months
|
58.0 Score
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
Baseline
|
43.8 units on a scale
Standard Deviation 21.9
|
|
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
1 Month
|
56.7 units on a scale
Standard Deviation 24.0
|
|
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
6 Months
|
63.6 units on a scale
Standard Deviation 23.8
|
|
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
12 Months
|
59.6 units on a scale
Standard Deviation 22.7
|
|
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
24 Months
|
58.0 units on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: 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 1 month, 6 months, 12 months, and 24 months is 31, 30, 25, and 19 respectively.
Left ventricle ejection fraction data available for 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis based on core lab assessment.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=38 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
1 Month
|
57.0 percent fraction
Standard Deviation 8.4
|
|
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
Baseline (6 Months)
|
56.2 percent fraction
Standard Deviation 10.0
|
|
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
6 Months
|
57.4 percent fraction
Standard Deviation 7.1
|
|
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
Baseline (12 Months)
|
56.6 percent fraction
Standard Deviation 10.1
|
|
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
12 Months
|
58.8 percent fraction
Standard Deviation 6.5
|
|
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
Baseline (24 Months)
|
57.8 percent fraction
Standard Deviation 8.8
|
|
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
Baseline (1 Month)
|
56.7 percent fraction
Standard Deviation 10.0
|
|
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
24 Months
|
56.6 percent fraction
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All available data for left ventricle ejection fraction at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per echo core lab.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
Baseline
|
56.9 percent fraction
Standard Deviation 10.2
|
|
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
1 Month
|
57.0 percent fraction
Standard Deviation 8.3
|
|
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
6 Months
|
57.8 percent fraction
Standard Deviation 7.1
|
|
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
12 Months
|
59.0 percent fraction
Standard Deviation 6.3
|
|
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
24 Months
|
56.9 percent fraction
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: Data was not collected.
Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: Data was not collected.
Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
NT-pro BNP [Full Analysis Data Set]
Baseline
|
2899.3 ng/L
Standard Deviation 2632.5
|
|
NT-pro BNP [Full Analysis Data Set]
6 Months
|
2563.1 ng/L
Standard Deviation 2510.2
|
|
NT-pro BNP [Full Analysis Data Set]
12 Months
|
2095.5 ng/L
Standard Deviation 2306.4
|
|
NT-pro BNP [Full Analysis Data Set]
24 Months
|
2119.1 ng/L
Standard Deviation 2461.3
|
|
NT-pro BNP [Full Analysis Data Set]
1 Month
|
2874.5 ng/L
Standard Deviation 2860.5
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: Data was not collected.
Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Bilirubin [Full Analysis Data Set]
Bilirubin Baseline
|
15.7 umol/L
Standard Deviation 17.5
|
|
Bilirubin [Full Analysis Data Set]
Bilirubin 1 Month
|
14.0 umol/L
Standard Deviation 13.4
|
|
Bilirubin [Full Analysis Data Set]
Bilirubin 6 Months
|
13.0 umol/L
Standard Deviation 5.8
|
|
Bilirubin [Full Analysis Data Set]
Bilirubin 12 Months
|
11.6 umol/L
Standard Deviation 7.9
|
|
Bilirubin [Full Analysis Data Set]
Bilirubin 24 Months
|
7.4 umol/L
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
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|---|---|
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Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
Baseline
|
52.8 mg/dL
Standard Deviation 30.3
|
|
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
1 Month
|
52.1 mg/dL
Standard Deviation 36.0
|
|
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
6 Months
|
64.2 mg/dL
Standard Deviation 55.1
|
|
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
12 Months
|
49.5 mg/dL
Standard Deviation 34.5
|
|
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
24 Months
|
50.5 mg/dL
Standard Deviation 55.7
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: Data was not collected.
Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
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|---|---|
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Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
Baseline
|
28.3 U/L
Standard Deviation 9.5
|
|
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
1 Month
|
31.9 U/L
Standard Deviation 18.3
|
|
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
6 Months
|
30.9 U/L
Standard Deviation 21.3
|
|
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
12 Months
|
32.3 U/L
Standard Deviation 10.9
|
|
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
24 Months
|
27.6 U/L
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: 1, 6, 12, and 24 months over baselinePopulation: The outcome is reported where data is available.
All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months.
Outcome measures
| Measure |
Cardioband Tricuspid Procedure
n=40 Participants
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
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|---|---|
|
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
12 Months
|
24.6 IU/L
Standard Deviation 12.2
|
|
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
Baseline
|
21.9 IU/L
Standard Deviation 14.0
|
|
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
1 Month
|
25.1 IU/L
Standard Deviation 23.8
|
|
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
6 Months
|
23.4 IU/L
Standard Deviation 18.4
|
|
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
24 Months
|
18.6 IU/L
Standard Deviation 10.2
|
Adverse Events
Cardioband Tricuspid Procedure
Serious events: 33 serious events
Other events: 34 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Cardioband Tricuspid Procedure
n=40 participants at risk
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
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|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Chronic lymphocytic leukaemia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiac Failure
|
32.5%
13/40 • Number of events 19 • 2 years
|
|
Cardiac disorders
Tricuspid valve incompetence
|
15.0%
6/40 • Number of events 6 • 2 years
|
|
Cardiac disorders
Atrioventricular block complete
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Cardiac disorders
Right ventricular failure
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Cardiac disorders
Cardiac failure congestive
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Cardiac disorders
Ventricular tachycardia
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Cardiac disorders
Angina unstable
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Bradycardia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiac tamponade
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiorenal syndrome
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Chest pain
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Chronotropic incompetence
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Coronary artery disease
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Coronary artery occlusion
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Coronary artery perforation
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Mitral valve incompetence
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Sinus node dysfunction
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Cardiac disorders
Ventricular fibrillation
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Endocrine disorders
Diabetic foot infection
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Endocrine disorders
Hyperglycaemia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Eye disorders
Cataract
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diverticulosis
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Jejunal ulcer
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
MalloryWeiss Syndrome
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Melaena
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Oesophageal rupture
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
General disorders
Death
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
General disorders
Hernia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Infections and infestations
Bacteraemia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Infections and infestations
Clostridium difficile colitis
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Infections and infestations
Erysipelothrix infection
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Infections and infestations
Herpes zoster
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Infections and infestations
Lung infection
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Infections and infestations
Staphylococcal sepsis
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Animal Bite
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Overdose
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Femur Fracture
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Nervous system disorders
Cerebrovascular accident
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Nervous system disorders
Cerebral Haemorrhage
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Nervous system disorders
Disturbance in attention
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Nervous system disorders
Transient ischaemic attack
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Product Issues
Device dislocation
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Somatic symptom disorder
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Suicide attempt
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
7.5%
3/40 • Number of events 6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
4/40 • Number of events 6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cardiopulmonary failure
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Vascular disorders
Haemorrhage
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Vascular disorders
Syncope
|
2.5%
1/40 • Number of events 4 • 2 years
|
|
Vascular disorders
Haematoma
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Vascular disorders
Peripheral artery occlusion
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Vascular disorders
Pulmonary embolism
|
2.5%
1/40 • Number of events 1 • 2 years
|
|
Vascular disorders
Stasis dermatitis
|
2.5%
1/40 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Cardioband Tricuspid Procedure
n=40 participants at risk
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.5%
9/40 • Number of events 10 • 2 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.5%
3/40 • Number of events 4 • 2 years
|
|
Cardiac disorders
Arteriospasm coronary
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
5/40 • Number of events 6 • 2 years
|
|
Cardiac disorders
Atrioventricular block complete
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Cardiac disorders
Cardiac failure
|
32.5%
13/40 • Number of events 20 • 2 years
|
|
Cardiac disorders
Cardiac failure congestive
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Cardiac disorders
Coronary artery occlusion
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Cardiac disorders
Mitral valve incompetence
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Cardiac disorders
Right ventricular failure
|
10.0%
4/40 • Number of events 5 • 2 years
|
|
Cardiac disorders
Tricuspid valve incompetence
|
20.0%
8/40 • Number of events 8 • 2 years
|
|
Cardiac disorders
Ventricular tachycardia
|
7.5%
3/40 • Number of events 4 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Diverticulum
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.0%
2/40 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Large intestine polyp
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Melaena
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
General disorders
Impaired healing
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Infections and infestations
Infection
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Infections and infestations
Pneumonia
|
17.5%
7/40 • Number of events 8 • 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
20.0%
8/40 • Number of events 11 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
2/40 • Number of events 5 • 2 years
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Investigations
Brain natriuretic peptide increased
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Investigations
C-reactive protein increased
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Investigations
Haemoglobin decreased
|
12.5%
5/40 • Number of events 5 • 2 years
|
|
Investigations
Troponin increased
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
4/40 • Number of events 4 • 2 years
|
|
Nervous system disorders
Cerebrovascular accident
|
5.0%
2/40 • Number of events 3 • 2 years
|
|
Product Issues
Device dislocation
|
10.0%
4/40 • Number of events 4 • 2 years
|
|
Product Issues
Device malfunction
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
30.0%
12/40 • Number of events 16 • 2 years
|
|
Renal and urinary disorders
Chronic Kidney disease
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
4/40 • Number of events 4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.0%
6/40 • Number of events 9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.0%
4/40 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Vascular disorders
Haematoma
|
5.0%
2/40 • Number of events 3 • 2 years
|
|
Vascular disorders
Haemorrhage
|
7.5%
3/40 • Number of events 3 • 2 years
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • Number of events 2 • 2 years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
5.0%
2/40 • Number of events 2 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place