VITALYST System for Heart Disease (VITALYST EFS Trial)

N/A

Recruiting

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new system called VITALYST to see if it is safe and feasible for use in patients undergoing a high-risk heart procedure called percutaneous coronary intervention."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, interventions like HR-PCI can typically include risks such as bleeding, blood vessel damage, irregular heartbeat, or reactions related to device implantation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure for reporting.