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Real-time MRI Right Heart Catheterization Using Passive Catheters

NCT01287026 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-04-05

No results posted yet for this study

Summary

Background:

\- Currently, heart catheterization procedures are guided by X-rays. Researchers are developing new techniques to perform heart catheterization without the use of X-rays by investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses, researchers are interested in performing a part of the standard X-ray catheterization procedure using MRI on individuals who are scheduled to have heart catheterization.

Objectives:

\- To examine the safety and feasibility of right-heart catheterization using MRI-guided catheters.

Eligibility:

\- Individuals at least 21 years of age who are undergoing a medically necessary heart catheterization procedure.

Design:

* The research MRI procedure will be performed either before or after standard X-ray guided heart catheterization.
* Participants will be transferred from an X-ray table onto an MRI table and advanced into the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood pressure and blood oxygen levels in the heart, and MRI scanning will be performed for approximately 30 minutes.

Conditions

  • Caridovascular Disease
  • Congenital Heart Disease
  • Pulmonary Hypertension

Interventions

PROCEDURE

Cardiac Real-time MRI RHC (Right Heart Catheterization)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Robert J Lederman, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-23
Primary Completion
2019-03-21
Completion
2019-03-21

Countries

  • United States

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 NCT01287026 on ClinicalTrials.gov