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Assessmet of Patients With PAH Right Ventricular Volume | Clinical Trials | Clareo Health

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Assessmet of Patients With PAH Right Ventricular Volume

Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension

NCT01557582•VentriPoint Diagnostics Ltd.

View on ClinicalTrials.gov

Summary

The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial will be defined as positive if the mean VMS-cMRI percent difference is \<10% and \>-10% at a 1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns for the VMS procedure.

Detailed Description

The objective of this study is: The comparison of the VMS and MRI values for EDV, ESV, and EF using 75 subjects. Secondary objectives are: The determination of VMS inter-observer and intra-observer variability of these quantities using 30 subjects.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Patients with Group 1 Pulmonary Arterial Hypertension
•IPAH
•HPAH
•APAH-CTD
•APAH-HIV
•APAH-PoPH
•APAH-Drugs/Toxins
•APAH-CHD repaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA
•APAH-CHD unrepaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA Patients who can be expected to lie motionless during imagine Males and females 12 years of age and older
•Left heart disease including clinically significant valvular disease, ,i.e. moderate or greater mitral regurgitation or stenosis or mild or greater aortic insufficiency or stenosis, pericardial disease, LV systolic dysfunction, i.e. LVEF \<40% or LVSF \<22%, and/or clinically significant LVDD
+12 more criteria

Exclusion Criteria

•Lack of informed consent (and assent as appropriate)

Locations (7)

University of Chicago

Chicago, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Baylor

Houston, Texas, United States

Toronto General Hospital

Tononto, Ontario, Canada

Key Dates

Start Date

April 1, 2012

Primary Completion Date

November 1, 2013

Completion Date

December 1, 2013

Last Updated

March 27, 2015

Enrollment

103

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

Ventripoint Medical System

DEVICE

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessmet of Patients With PAH Right Ventricular Volume

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization