VITALYST System for Heart Disease

(VITALYST EFS Trial)

Recruiting at 4 trial locations

Overseen By Amy Maurer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must not be taking: Inotropes, Vasopressors, Anticoagulants, others

Disqualifiers: STEMI, Cardiac arrest, Liver dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours or until hospital discharge

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).

Eligibility Criteria

The VITALYST EFS is for adults aged 18 to less than 90 who need a non-emergency procedure (HR-PCI) for heart vessel blockages and have reduced heart pump function. They must agree to the study's terms, be evaluated by a heart team including a surgeon, and not be in an emergency situation.

Inclusion Criteria

My heart team, including a cardiac surgeon, agrees HR-PCI is right for me.

Subject provides signed informed consent

I need a non-emergency procedure for my heart's blocked vessels and my heart's pumping ability is reduced.

Exclusion Criteria

I had a severe heart attack within the last 3 days and my heart markers are still high.

Subject has other disease condition(s) resulting in the subject being unsuitable for participation in the clinical trial (e.g., advanced malignancy with limited expected survival)

I have had a stroke or a mini-stroke in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The VITALYST System is used to provide temporary circulatory support during high-risk percutaneous coronary interventions

72 hours or until hospital discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VITALYST System

Trial Overview This trial tests the VITALYST System during elective high-risk procedures to open blocked arteries of the heart. It aims to assess how feasible and safe this system is when used in patients with serious coronary artery disease.

Participant Groups

Group I: High Risk PCI Patients Experimental Treatment 1 Intervention

Patients undergoing non-emergent, high-risk percutaneous coronary interventions

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology