15 Participants Needed

VITALYST System for Heart Disease

(VITALYST EFS Trial)

Recruiting at 4 trial locations
AO
AM
Overseen ByAmy Maurer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.
See 28 more

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
1Treatment groups
Experimental Treatment
Group I: High Risk PCI PatientsExperimental Treatment1 Intervention
Patients undergoing non-emergent, high-risk percutaneous coronary interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

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 profile image

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

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