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The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARTO system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARTO System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Event Rate to 30 Days post-procedure | Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure | <=30 days post procedure |
| Mitral regurgitation grade and change from baseline to 30 days | <=30 days post procedure | |
| Device Technical Success | At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure | procedural |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrejs Erglis, MD | Pauls Stradins Clinical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Wesley Hospital | Auchenflower | Queensland | 4066 | Australia | ||
| St Andrews Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29191334 | Derived | Erglis A, Narbute I, Poupineau M, Hovasse T, Kamzola G, Zvaigzne L, Erglis M, Erglis K, Greene S, Rogers JH. Treatment of Secondary Mitral Regurgitation in Chronic Heart Failure. J Am Coll Cardiol. 2017 Dec 5;70(22):2834-2835. doi: 10.1016/j.jacc.2017.09.1110. No abstract available. | |
| 26117461 | Derived | Rogers JH, Thomas M, Morice MC, Narbute I, Zabunova M, Hovasse T, Poupineau M, Rudzitis A, Kamzola G, Zvaigzne L, Greene S, Erglis A. Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial). JACC Cardiovasc Interv. 2015 Jul;8(8):1095-1104. doi: 10.1016/j.jcin.2015.04.012. Epub 2015 Jun 24. |
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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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| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Warringal Private Hospital | Heidelberg | Australia |
| The Mount Hospital | Perth | Australia |
| ICPS | Massy | France |
| IRCCS San Donato | Milan | Italy |
| Pauls Stradins Clinical University Hospital | Riga | 1002 | Latvia |
| Brighton and Sussex University Hospitals | Brighton | United Kingdom |
| St Thomas' Hospital | London | United Kingdom |