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| ID | Type | Description | Link |
|---|---|---|---|
| 09/1819 | Other Identifier | FEKI |
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The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanting ePTFE sutures | Experimental | Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoChord DS1000 Artificial Chordae Delivery System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation <= 2+ at the time of the procedure AND maintained MR reduction of <= 2+ at 30 days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Safety | the rate of Major Adverse Events (MAE) defined as a combined endpoint of: death, MI, reoperation for failed surgical repair, non-elective cardiovascular surgery to treat an adverse event, procedural ventilation > 48 hours, procedure-related transfusion of > 2 units blood product, stroke, renal failure, deep wound infection, new onset of permanent AF, and septicemia, through 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anno Diegeler, MD | Herz und Gefäß-Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Skejby | Aarhus | 8200 | Denmark | |||
| Kerckhoff-Klinik |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24076529 | Derived | Seeburger J, Rinaldi M, Nielsen SL, Salizzoni S, Lange R, Schoenburg M, Alfieri O, Borger MA, Mohr FW, Aidietis A. Off-pump transapical implantation of artificial neo-chordae to correct mitral regurgitation: the TACT Trial (Transapical Artificial Chordae Tendinae) proof of concept. J Am Coll Cardiol. 2014 Mar 11;63(9):914-9. doi: 10.1016/j.jacc.2013.07.090. Epub 2013 Sep 24. |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D008945 | Mitral Valve Prolapse |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016127 | Heart Valve Prolapse |
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| 30 days |
| Bad Nauheim |
| Germany |
| Herz und Gefäß-Klinik | Bad Neustadt an der Saale | Germany |
| Herzzentrum Leipzig | Leipzig | Germany |
| Klinik für Herz-und Gefäßchirurgie | Munich | Germany |
| San Raffaele | Milan | Italy |
| Ospedale San Giovanni Battista "Molinette" | Torino | Italy |
| Vilniaus Universiteto ligonines Santariskiu | Vilnius | Lithuania |