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Real-time MRI Right Heart Catheterization Using Passive Catheters

Real-Time MRI Right Heart Catheterization Using Passive Catheters

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01287026
Enrollment
150
Registered
2011-02-01
Start date
2011-02-23
Completion date
2019-03-21
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caridovascular Disease, Congenital Heart Disease, Pulmonary Hypertension

Keywords

MRI Catheterization, Right Heart Catheterization, Pulmonary Artery Catheterization, MRI Safety, Jugular Vein Catheterization, Heart Catheterization, Heart Disease, Cardiovascular Disease

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.

Interventions

PROCEDURECardiac Real-time MRI RHC (Right Heart Catheterization)

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: Age greater than or equal to 2 years old Undergoing medically necessary diagnostic or interventional right and/or left cardiovascular catheterization

Exclusion criteria

: Cardiovascular instability including ongoing acute myocardial infarction, refractory angina or ischemia, and decompensated congestive heart failure. Women who are pregnant or nursing Unable to undergo magnetic resonance imaging: * Cardiac pacemaker or implantable defibrillator * Cerebral aneurysm clip * Neural stimulator (e.g. TENS-Unit) * Any type of ear implant * Ocular foreign body (e.g. metal shavings) * Metal shrapnel or bullet. * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI

Design outcomes

Primary

MeasureTime frameDescription
To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI- guidance andOngoingThere will be no heating or adverse events related to the MRI RHC.

Secondary

MeasureTime frame
To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization proceduresOngoing
To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humansOngoing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026