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Safety and performance evaluation of the preCARDIA System for patients with ADHF.
The objective of this early feasibility study is to evaluate the safety and performance of the preCARDIA System for Superior Vena Caval (SVC) intermittent mechanical occlusion as a therapeutic approach in significantly congested subjects with Acute Decompensated Heart Failure (ADHF), who are not diuresing adequately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHF Patients | Experimental | Treatment with preCARDIA System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preCARDIA system | Device | Intermittent occlusion of the SVC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Major Adverse Events through 90 days post-discharge. | MAE is defined as death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke or prolongation of heart failure- related hospitalization attributable to the preCARDIA device or procedure. | 90 days post-discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Heart & Vascular | Lakewood | Colorado | 80226 | United States | ||
| Medstar Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41389079 | Derived | Yousefzai R, Bhimaraj A, Kiernan MS, Abraham J, Gorgoshvili I, Tedford RJ, Desai S, Vorovich EE, Benzuly KH, Miranda D, Kanwar MK, Sauer AJ, Rinde-Hoffman DA, Dumitru I, Hernandez-Montfort J, Aghili N, Sheikh FH, Basuray A, Bodnar J, Curran J, Burkhoff D, Kapur NK. Mechanically Reducing Cardiac Preload With the preCARDIA System in Acutely Decompensated Heart Failure. JACC Heart Fail. 2026 Mar;14(3):102841. doi: 10.1016/j.jchf.2025.102841. Epub 2025 Dec 13. | |
| 35000420 |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Northwestern | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | 56303 | United States |
| OhioHealth | Columbus | Ohio | 43214 | United States |
| Providence Health & Services | Portland | Oregon | 97225 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Baylor, Scott & White Medical Center - Temple | Temple | Texas | 76508 | United States |
| Inova Health System | Falls Church | Virginia | 22042 | United States |
| Derived |
| Kapur NK, Kiernan MS, Gorgoshvili I, Yousefzai R, Vorovich EE, Tedford RJ, Sauer AJ, Abraham J, Resor CD, Kimmelstiel CD, Benzuly KH, Steinberg DH, Messer J, Burkhoff D, Karas RH. Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients With Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study. Circ Heart Fail. 2022 Feb;15(2):e008934. doi: 10.1161/CIRCHEARTFAILURE.121.008934. Epub 2022 Jan 10. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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