NCT01287026

Real-time MRI Right Heart Catheterization Using Passive Catheters

Real-Time MRI Right Heart Catheterization Using Passive Catheters

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 2 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Heart catheterization is a minimally invasive procedure to measure pressure and inject dye into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure and which fails to visualize soft tissue. We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization with tissue visualization but without X-ray radiation. In the first phase of this protocol we showed that comprehensive right-sided heart catheterization is feasible in adult patients, using commercially available MRI-compatible ( passive ) catheters. In the second phase of the protocol, we began performing systematic right-sided heart catheterization without X-ray whenever possible. We will assess the hearts response to hemodynamic provocation during MRI catheterization tailored to the patient s problem. We will use this protocol to further refine the technique If successful, this will enable future testing of devices for adult and pediatric MRI-guided catheterization, such as special active wire guides, which may lead to new non-surgical treatments of cardiovascular disease.

Conditions

• Caridovascular Disease
• Congenital Heart Disease
• Pulmonary Hypertension

Interventions

Type	Name	Description
PROCEDURE	Cardiac Real-time MRI RHC (Right Heart Catheterization)

Timeline

• Start date: 2011-02-23
• Primary completion: 2019-03-21
• Completion: 2019-03-21
• First posted: 2011-02-01
• Last updated: 2019-04-05

Locations

1 site across 1 country: United States