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A Study Of 4D Virtual Catheter (4D VCath) For Multi-Factorial Hemodynamics In Pulmonary Hypertension

Overview

About this study

The purpose of this study is to extend innovation to the right heart and develop a '4D RightHeart virtual catheter (4D RH vCath).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Aim #1: Healthy Volunteers

Inclusion Criteria:

  • Age ≥18 years old
  • Able to consent
  • Able to complete the MRI safety questionnaire

Exclusion Criteria:

  • Age <18 years old
  •  Contraindication to MRI
  •  Adults unable to consent
  • Pregnant or breastfeeding women
  • Prisoners

Aim #2: PH Patients

Inclusion Criteria:

  • Age ≥18 years old
  • Able to consent
  • Able to complete the MRI safety questionnaire
  • Diagnosed with PAH within the past 12 months OR newly diagnosed PH with high pre-test probability of PVH

Exclusion Criteria:

  • Age <18 years old
  • Contraindication to MRI
  • Adults unable to consent
  • Pregnant or breastfeeding women 5) Prisoners

Aim #3: PAH Patients

Only the PAH patients previously enrolled into Aim #2 will be included in Aim #3, which is the 1- year follow-up visit after the same-day RHC/MRI visit.
The inclusion/exclusion criteria for these participants will be re-evaluated at the time of 1-year follow-up visit to confirm no changes have occurred since the last study visit.

Inclusion Criteria:

  • Age ≥18 years old
  • Able to consent
  • Able to complete the MRI safety questionnaire
  • Diagnosed with PAH and previously enrolled in Aim #2

Exclusion Criteria:

  • Age <18 years old
  • Contraindication to MRI
  • Adults unable to consent
  • Pregnant or breastfeeding women
  • Prisoners
  • Not previously enrolled in Aim #2

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/11/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Christopher Francois, M.D.

Contact us for the latest status

Contact information:

Ryan Jacobson

5075388024

jacobson.ryan1@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20598538

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