Physio-Anatomy Clinical Data Collection Study

Launched by GENTUITY, LLC · Mar 31, 2022

Keywords

ClinConnect Summary

The Physio-Anatomy Clinical Data Collection Study is a research project aimed at understanding how certain heart procedures work for patients with coronary stenosis, which is a narrowing of the heart arteries. This study involves using approved medical technologies and medications during heart tests called cardiac catheterizations to gather important data about the effectiveness of these procedures. The trial is currently looking for participants, specifically individuals aged 18 and older who have signs of heart disease and are scheduled for a procedure to check their heart's blood flow.

To be eligible for this study, participants should be in good enough health to undergo a heart catheterization and be able to give written consent to join. However, there are some conditions that would prevent someone from participating, such as having a recent heart attack, severe heart failure, or being pregnant. If you decide to join the study, you can expect to receive standard care while contributing to valuable research that may help improve treatment options for patients with heart conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients \>18 years of age.
• • Patients provide written informed consent.
• • Clinical presentation consistent with suspected coronary disease.
• • Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.
• Exclusion Criteria:
• • Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
• • Contraindication for FFR examination or administration of vasodilators.
• • Bacteremia or sepsis.
• • Major coagulation system abnormalities.
• • Severe hemodynamic instability or shock.
• • Heart Failure NYHA Class IV.
• • Severe valvular heart disease.
• • Prior heart transplant.
• • Acute renal failure based on diagnostic practice of the treating physician at time of screening.
• • Patient is pregnant.
• • Patient is currently enrolled in another clinical study that may impact the results of this study.
• • Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their