Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

• ClinicalTrials.gov Identifier: NCT02645539
• Recruitment Status: Unknown
• First Posted: January 1, 2016
• Last Update Posted: November 13, 2019
• Sponsor: NuPulseCV
• Information provided by (Responsible Party): NuPulseCV

Tracking Information

• First Submitted Date: December 30, 2015
• First Posted Date: January 1, 2016
• Last Update Posted Date: November 13, 2019
• Actual Study Start Date: April 2016
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 10, 2018): Survival to transplant or stroke-free survival [ Time Frame: 30 days ]
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: November 2, 2018)

• Number of patients who deteriorate requiring escalation of treatment [ Time Frame: 30 days ]
• Rate of occurrence of all adverse events [ Time Frame: 30 days ]
• Rate of occurrence of procedure-related adverse events [ Time Frame: 30 days ]
• Rate of occurrence of serious device-related adverse events [ Time Frame: 30 days ]
• Number of patients demonstrating improvement in NYHA Classification [ Time Frame: 30 days ]
• Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL) [ Time Frame: 30 days ]
• Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST) [ Time Frame: 30 days ]
• Number of patients demonstrating improvement in Seattle Heart Failure Model Score [ Time Frame: 30 days ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
• Official Title: A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
• Brief Summary: The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Intervention

Device: intravascular ventricular assist system (iVAS)

A mechanical circulatory support device using the principles of counterpulsation.

Other Names:

• iVAS
• Blood Pump
• NuPulse

Study Arms

Experimental: Single Arm

All patients are treated with the intravascular ventricular assist system (iVAS).

Intervention: Device: intravascular ventricular assist system (iVAS)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 2, 2018): 100
• Original Enrollment: Not Provided
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Main Inclusion Criteria:

1. At least 18 years of age.
2. If female, are postmenopausal or surgically sterilized, or have a negative pregnancy test within seven (7) days of invasive testing.
3. Advanced heart failure (NYHA Class III or IV)

Main Exclusion Criteria:

1. Hypotension treated with the following medications: epinephrine, norepinephrine, vasopressin, methylene blue, phenylephrine, or angiotensin II.
2. Receiving more than two inotropes.
3. Subclavian stenosis or stent.
4. Currently receiving circulatory support including ECMO, Impella, TandemLife or equivalents; or any durable VAD.
5. Atrial fibrillation without ventricular pacing.
6. Concomitant, non-cardiac disease process with life expectancy < 1 year.
7. Significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta, or an extremely tortuous aorta.
8. Severe end-organ dysfunction or failure.
9. Any other condition the heart team believes inappropriate for this study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02645539
• Other Study ID Numbers: PRO-10001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: NuPulseCV
• Original Responsible Party: [Redacted]
• Current Study Sponsor: NuPulseCV
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: NuPulseCV
• Verification Date: November 2019