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To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
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| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure | The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement
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| Name | Affiliation | Role |
|---|---|---|
| Joerg Seeberger, MD | Leipzig University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux Heart University Hospital (CHU) | Bordeaux | France | ||||
| Herzzentrum Dresden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | All Subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One patient did not have baseline information reported |
| 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 | Procedure Success | To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure | Posted | Count of Participants | Participants | The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day. |
|
|
Index procedure though 1-year follow-up visit
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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 | Overall | All patients | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Regurgitation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Regurgitation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori E Adels, PhD | NeoChord, Inc. | 1-952-698-7804 | ladels@neochord.com |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008945 | Mitral Valve Prolapse |
| ID | Term |
|---|---|
| D016127 | Heart Valve Prolapse |
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| Dresden |
| Germany |
| Asklepios Hospital St. Georg | Hamburg | Germany |
| University Medical Center Hamburg | Hamburg | Germany |
| University of Padova Medical School | Padova | 35127 | Italy |
| Vilniaus Universiteto ligonines Santariskiu | Vilnius | Lithuania |
| Universitätsspital Basel | Basel | CH-4031 | Switzerland |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One patient did not have baseline information reported | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| 126 |
| 37 |
| 126 |
| 9 |
| 126 |
| Dyspnea | General disorders | Non-systematic Assessment |
|
| Hepatic complication | Hepatobiliary disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Neurological complication | Nervous system disorders | Non-systematic Assessment |
|
| Renal dysfunction | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory complication | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Valve intervention | Surgical and medical procedures | Systematic Assessment |
|
| Peripheral vascular complication | Vascular disorders | Non-systematic Assessment |
|
| Other cardiac complication | Cardiac disorders | Non-systematic Assessment |
|
| Other non-cardiovascular complication | General disorders | Non-systematic Assessment |
|
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