Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
This is a single-arm, non-randomized study designed to assess the preliminary safety and clinical performance of the NuPulseCV iVAS.
Data obtained from the study will be used to make device modifications, refine the patient population, and inform the design a future clinical trial suitable for assessing longer-term use in heart failure patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All patients are treated with the intravascular ventricular assist system (iVAS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravascular ventricular assist system (iVAS) | Device | A mechanical circulatory support device using the principles of counterpulsation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival to transplant or stroke-free survival | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who deteriorate requiring escalation of treatment | 30 days | |
| Rate of occurrence of all adverse events | 30 days | |
| Rate of occurrence of procedure-related adverse events |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori Rhoten | Contact | 1-800-216-1778 | CTT@nupulsecv.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32264715 | Derived | Uriel N, Jeevanandam V, Imamura T, Onsager D, Song T, Ota T, Juricek C, Combs P, Lammy T, Patel-Raman S, Woolley JR, Sayer G, Milano C, Schroder J, Molina E, Grinstein J, Suarez E, Estep JD, Aggarwal S, Silvestry S, Raval N; iVAS Investigators. Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial. Circ Heart Fail. 2020 Apr;13(4):e006666. doi: 10.1161/CIRCHEARTFAILURE.119.006666. Epub 2020 Apr 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days |
| Rate of occurrence of serious device-related adverse events | 30 days |
| Number of patients demonstrating improvement in NYHA Classification | 30 days |
| Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL) | 30 days |
| Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST) | 30 days |
| Number of patients demonstrating improvement in Seattle Heart Failure Model Score | 30 days |
| Advent Health | Recruiting | Orlando | Florida | 32804 | United States |
|
| University of Chicago Medicine | Recruiting | Chicago | Illinois | 60637 | United States |
|
| NorthShore University Health System | Recruiting | Evanston | Illinois | 60201 | United States |
|
| Saint Vincent Hospital | Recruiting | Indianapolis | Indiana | 46260 | United States |
|
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70121 | United States |
|
| Brigham & Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Saint Luke's Mid-America Heart Institute | Completed | Kansas City | Missouri | 64111 | United States |
| University of Nebraska | Recruiting | Omaha | Nebraska | 68198 | United States |
|
| New York University | Recruiting | New York | New York | 10016 | United States |
|
| Columbia University Medical Center / New York-Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Abington Hospital - Jefferson Health | Recruiting | Abington | Pennsylvania | 19001 | United States |
|
| Penn State Health Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
|
| Houston Methodist Research Institute | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Utah Hospital | Recruiting | Salt Lake City | Utah | 84132 | United States |
|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided