Real-time MRI Right Heart Catheterization Using Passive Catheters

Phase 1

Completed

• Conditions: Congenital Heart Disease; Pulmonary Hypertension; Caridovascular Disease
• Interventions: Procedure: Cardiac Real-time MRI RHC (Right Heart Catheterization)

• Registration Number: NCT01287026
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief 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.

Study Timeline

• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-01
• Study Start: 2011-02-23
• Status Verified: 2019-03-21
• Primary Completion: 2019-03-21
• Study Completion: 2019-03-21
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cardiac Real-time MRI RHC (Right Heart Catheterization)	Open Label

Primary Outcome Measures

Name	Time	Method
To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI- guidance and	Ongoing	There will be no heating or adverse events related to the MRI RHC.

Secondary Outcome Measures

Name	Time	Method
To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures	Ongoing
To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans	Ongoing

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States