VITALYST System for Heart Disease

(VITALYST EFS Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the VITALYST System, a new medical device, to determine its safety and effectiveness for individuals undergoing high-risk heart procedures known as percutaneous coronary interventions (PCI). It targets those with complex heart issues, such as severe blockages in major heart vessels and reduced heart function. Suitable candidates have heart disease with significant blockages and a heart function of 50% or less. The trial aims to assist those requiring careful management of their heart condition. As an unphased trial, it provides patients the chance to contribute to groundbreaking research that could enhance heart treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the VITALYST System is safe for high-risk PCI patients?

Research has shown that the VITALYST System, used for heart procedures, is still undergoing safety testing in people. Current studies are exploring its use in non-emergency, high-risk heart procedures. These studies are in the early stages, so the treatment's safety is still being determined.

In other studies on similar devices, most patients responded well to the treatment. Some side effects, or unwanted reactions, have been observed, but they are usually mild. Since this type of device is new, more research is needed to understand all possible risks. Its early study phase means that while some safety information is available, it is not yet complete. Anyone considering joining a study should consult their doctor to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VITALYST System is unique because it is designed to support patients undergoing high-risk percutaneous coronary interventions (PCI), which are usually performed to open blocked coronary arteries. Unlike traditional options that primarily rely on medications like antiplatelets and statins or mechanical devices like stents, the VITALYST System offers a novel approach tailored for non-emergent, high-risk scenarios. Researchers are excited about this system because it potentially enhances the safety and effectiveness of high-risk PCI procedures, offering new hope for patients who might otherwise have limited options. By focusing on these challenging cases, the VITALYST System aims to improve outcomes and expand the possibilities of interventional cardiology.

What evidence suggests that the VITALYST System is effective for heart disease?

Research shows that the VITALYST System provides temporary heart support during high-risk heart procedures, helping maintain blood flow during complex surgeries. In this trial, the VITALYST System will assist patients undergoing non-emergent, high-risk percutaneous coronary interventions. Studies on similar devices suggest they can reduce complications and improve outcomes for high-risk patients. While specific data on VITALYST is still being gathered, it builds on the known benefits of mechanical heart support devices, which have proven helpful for patients with serious heart issues requiring planned, non-emergency procedures. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06132568

VITALYST Early Feasibility Study in High-Risk PCI Patients ... The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI).

2. trialx.com trialx.com/clinical-trials/listings/291399/vitalyst-early-feasibility-study-in-high-risk-pci-patients-vitalyst-efs/

VITALYST Early Feasibility Study in High-Risk PCI Patients ... The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous ...

3. withpower.com withpower.com/trial/phase-heart-diseases-2024-fffc5

VITALYST System for Heart Disease · Info for Participants 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 ...

4. eurointervention.pcronline.com eurointervention.pcronline.com/article/mechanical-circulatory-support-for-complex-high-risk-percutaneous-coronary-intervention/pdf

State-of-the-Art The evidence base evaluating the use of mechanical circulatory support (MCS) devices in complex, high-risk percutaneous coronary intervention is evolving ...

5. eurointervention.pcronline.com eurointervention.pcronline.com/article/mechanical-circulatory-support-for-complex-high-risk-percutaneous-coronary-intervention

Mechanical circulatory support for complex, high-risk ... In this review, we will critically appraise the current literature evaluating the benefits and risks of using MCS devices to support high-risk PCI.

6. tctmd.com tctmd.com/slide/special-late-breaking-clinical-science-abstract-mechanical-circulatory-support-high-risk-pci

Mechanical Circulatory Support for High-Risk PCI With a ... Mechanical circulatory support for high-risk PCI with a novel VITALYST system: early feasibility and safety results of the VITALYST study.