| Primary | Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) | Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE) | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| MSAE | | | | SADE | | |
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| Primary | Access, Deployment and Positioning of the Cardioband Device | Successful access, deployment and positioning of the Cardioband device | | Posted | | Count of Participants | | Participants | | Intra-procedure | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Technical Success | Successful access, deployment and positioning of the Cardioband device and septolateral reduction. | | Posted | | | | | | 1, 6, 12, and 24 months | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 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. | 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. | Posted | | Count of Participants | | Participants | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Tricuspid Regurgitation [Full Analysis Data Set] | 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. | The outcome is reported where data is available. | Posted | | Count of Participants | | Participants | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab | 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. | Posted | | Mean | Standard Deviation | cm^2 | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] | 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. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | cm^2 | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Regurgitant Volume [Paired Baseline and Follow-Up] | Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab. | 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. | Posted | | Mean | Standard Deviation | ml | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Regurgitant Volume [Full Analysis Data Set] | All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | ml | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | TAPSE [Paired Baseline and Follow-Up] | Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab. | 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. | Posted | | Mean | Standard Deviation | cm | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | TAPSE [Full Analysis Data Set] | 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. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | cm | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | NYHA [Paired Baseline and Follow-Up] | NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure:
- Class I - No symptoms and no limitation in ordinary physical activity
- Class II - Mild symptoms and slight limitation during ordinary activity.
- Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
- Class IV - Severe limitations. Experiences symptoms even while at rest.
| 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. | Posted | | Count of Participants | | Participants | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | NYHA [Full Analysis Data Set] | 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:
- Class I - No symptoms and no limitation in ordinary physical activity
- Class II - Mild symptoms and slight limitation during ordinary activity.
- Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
- Class IV - Severe limitations. Experiences symptoms even while at rest.
| The outcome is reported where data is available. | Posted | | Count of Participants | | Participants | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 6MWT [Paired Baseline and Follow-Up] | Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline. | 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. | Posted | | Mean | Standard Deviation | Meters | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | 6MWT [Full Analysis Data Set] | Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | Meters | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | 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. | 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. | Posted | | Mean | Standard Deviation | Score | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] | 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. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | units on a scale | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | 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. | 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. | Posted | | Mean | Standard Deviation | percent fraction | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] | 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. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | percent fraction | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set] | Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline. | | Posted | | | | | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set] | Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline. | | Posted | | | | | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | NT-pro BNP [Full Analysis Data Set] | N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | ng/L | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Diuretic Therapy | Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline. | | Posted | | | | | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Bilirubin [Full Analysis Data Set] | Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | umol/L | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] | All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | mg/dL | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Activity by Wearable Device | Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline. | | Posted | | | | | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] | All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | U/L | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] | All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months. | The outcome is reported where data is available. | Posted | | Mean | Standard Deviation | IU/L | | 1, 6, 12, and 24 months over baseline | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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