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This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.
Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair System | Device | The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events (MAEs) | Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair [TEER] or mitral valve surgery) | 30 days |
| Mitral Regurgitation (MR) Reduction to <=2+ | MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+). | 30 days, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores | KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Mitral Regurgitation eligible to receive the PASCAL device
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| Name | Affiliation | Role |
|---|---|---|
| Joerg Hausleiter, Prof. | MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMU Klinikum der Universität München | München | Bavaria | 81377 | Germany | ||
| Immanuel Klinikum Bernau |
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| ID | Title | Description |
|---|---|---|
| FG000 | Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral valve repair with PASCAL implanted via transcatheter procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral valve repair with PASCAL implanted via transcatheter procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Adverse Events (MAEs) | Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair [TEER] or mitral valve surgery) | Analysis includes patients who had an MAE or who were followed for at least 30 days. Patients may experience more than one MAE. | Posted | Count of Participants | Participants | 30 days |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Edwards PASCAL Transcatheter Mitral Valve Repair System | Mitral valve repair with PASCAL implanted via transcatheter procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | STS/ACC TVT Registry | Systematic Assessment |
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Interpretation of some outcome measures is limited by significant incomplete and/or missing data due to retrospective data collection, differences in data collected as part of standard of care across sites, and use of alternative follow-up data collection methods in lieu of in-person clinical visits. Additionally, this registry did not use an echocardiography core laboratory to assess echocardiography parameters or a clinical events committee to adjudicate adverse events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ted Feldman | Edwards Lifesciences | 949-250-2500 | Feldman_Info@edwards.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2019 | May 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2019 | May 12, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline, 30 days, 12 months |
| Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS) | Patient's self-rated health on a visual analog scale (0-100 points; 0=worst health you can imagine and 100=best health you can imagine). | Baseline, 30 days, 12 months |
| New York Heart Association (NYHA) Functional Classification | NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity: 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. | Baseline, 30 days, 12 months |
| 6-Minute Walk Test (6MWT) | 6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes. | Baseline, 30 days, 12 months |
| Bernau bei Berlin |
| Brandenburg |
| 16321 |
| Germany |
| Universitätsklinikum Gießen | Giessen | Hesse | 35392 | Germany |
| Georg-August-Universität Göttingen, Universitätsmedizin Göttingen | Göttingen | Lower Saxony | 37075 | Germany |
| Herzzentrum Köln | Cologne | Nord Rhine Westphalia | 50937 | Germany |
| Herz- und Diabeteszentrum NRW - Bad Oeynhausen | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| Herzzentrum der Universitätsklinik Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| St.-Johannes-Hospital Dortmund | Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Elisabeth-Krankenhaus Essen | Essen | North Rhine-Westphalia | 45138 | Germany |
| Universitätsmedizin der Johannes Gutenberg Universität Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Herzzentrum Universitätsklinik Dresden | Dresden | Saxony | 01307 | Germany |
| Heart Centre of the University Leipzig | Leipzig | Saxony | 04289 | Germany |
| Kath. Marienkrankenhaus Hamburg GmbH | Hamburg | 22087 | Germany |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Data unavailable for 2 patients | Mean | Standard Deviation | kg/m^2 |
|
| STS Score for Mitral Valve Repair | The Society of Thoracic Surgeons (STS) Score for Mitral Valve Repair is a validated risk-prediction model for operative mortality associated with mitral valve repair surgery based on the STS Adult Cardiac Care Surgery Database. In general, an STS predicted risk score of 4%-8% is considered intermediate risk and 8% or greater is considered high risk | Data unavailable for 62 patients | Mean | Standard Deviation | % |
|
| EuroScore II | The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II is a cardiac risk model for predicting mortality after cardiac surgery. The higher the score, the higher the risk of an adverse outcome EuroScore II risk levels are as follows: Low risk: <8% Moderate risk: 8-10% High risk: >10% | Data unavailable for 17 patients | Mean | Standard Deviation | % |
|
| New York Heart Association (NYHA) Functional Class | NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity: 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. | Data unavailable for 4 patients | Count of Participants | Participants |
|
| Mitral Regurgitation (MR) Etiology | Underlying cause of MR, includes functional, degenerative, mixed (both functional and degenerative), and other | Data unavailable for 2 patients | Count of Participants | Participants |
|
| Mitral Regurgitation (MR) Severity | MR severity was assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+). | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Mitral Regurgitation (MR) Reduction to <=2+ | MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+). | Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints. | Posted | Count of Participants | Participants | 30 days, 12 months |
|
|
|
| Secondary | Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores | KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life). | Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 30 days, 12 months |
|
|
|
| Secondary | Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS) | Patient's self-rated health on a visual analog scale (0-100 points; 0=worst health you can imagine and 100=best health you can imagine). | Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 30 days, 12 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Classification | NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity: 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. | Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints. | Posted | Count of Participants | Participants | Baseline, 30 days, 12 months |
|
|
|
| Secondary | 6-Minute Walk Test (6MWT) | 6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes. | Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints. | Posted | Mean | Standard Deviation | meter | Baseline, 30 days, 12 months |
|
|
|
| 19 |
| 220 |
| 82 |
| 220 |
| 0 |
| 220 |
| Readmission - Cardiac (not Heart Failure) | Cardiac disorders | STS/ACC TVT Registry | Systematic Assessment |
|
| Readmission - Heart Failure | Cardiac disorders | STS/ACC TVT Registry | Systematic Assessment |
|
| Atrial Septal Defect (ASD) Closure Due to Transseptal Catheterizaton | Injury, poisoning and procedural complications | STS/ACC TVT Registry | Systematic Assessment |
|
| Bleeding at Access Site | Injury, poisoning and procedural complications | STS/ACC TVT Registry | Systematic Assessment |
|
| Hematoma at Access Site | Injury, poisoning and procedural complications | STS/ACC TVT Registry | Systematic Assessment |
|
| Major Vascular Complication | Injury, poisoning and procedural complications | STS/ACC TVT Registry | Systematic Assessment |
|
| Other Device Related Event | Product Issues | STS/ACC TVT Registry | Systematic Assessment | Includes but is not limited to Single Leaflet Device Attachment events that occurred during follow-up. |
|
| Single Leaflet Device Attachment | Product Issues | STS/ACC TVT Registry | Systematic Assessment | Includes Single Leaflet Device Attachment events reported during procedure visit only. Single Leaflet Device Attachment events occurring during follow-up reported as Other Device Related Event. |
|
| New Requirement for Dialysis | Renal and urinary disorders | STS/ACC TVT Registry | Systematic Assessment |
|
| Complication Requiring Transcatheter or Surgical Intervention | Surgical and medical procedures | STS/ACC TVT Registry | Systematic Assessment |
|
| Mitral Valve Re-Intervention | Surgical and medical procedures | STS/ACC TVT Registry | Systematic Assessment |
|
| Readmission - Non-Cardiac (Follow Up) | Surgical and medical procedures | STS/ACC TVT Registry | Systematic Assessment |
|
| Unplanned Other Cardiac Surgery or Intervention (Not Mitral Valve Re-Intervention) | Surgical and medical procedures | STS/ACC TVT Registry | Systematic Assessment |
|
| Unplanned Vascular Surgery or Intervention (for Bleeding or Access Site Complication) | Surgical and medical procedures | STS/ACC TVT Registry | Systematic Assessment |
|
| Life-Threatening Bleeding | Vascular disorders | STS/ACC TVT Registry | Systematic Assessment |
|
| Major Bleeding Event | Vascular disorders | STS/ACC TVT Registry | Systematic Assessment |
|
| Other Bleed | Vascular disorders | STS/ACC TVT Registry | Systematic Assessment |
|
Publication or presentation of the overall registry results and/or site-specific results requires prior written approval of Edwards.
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|
| 12 Months |
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| 12 Months |
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| Class III |
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| Class IV |
|
| 30 Days |
|
|
| 12 Months |
|
|
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| 12 Months |
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