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OpSens PRIME CLASS

NCT05070130 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2023-04-27

No results posted yet for this study

Summary

In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment. Post-TAVR FFR will be taken as the reference for predicting ischemic lesions, and angiography and physiology - FFR and diastolic pressure ratio (dPR) - will be performed immediately before and after TAVR, in an all-comer multicentric observational study.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

dPR and FFR

OpSens non-hyperemic dPR and/or OpSens FFR

Sponsors & Collaborators

  • Opsens, Inc.

    lead INDUSTRY

Principal Investigators

  • Enrique Gutierrez Ibanes, MD · Hospital Gregoio Maranon

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2023-03-15
Completion
2023-04-04

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05070130 on ClinicalTrials.gov