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Pericardiocentesis With Magnetic Resonance Imaging

Real-time MRI Pericardiocentesis Using Passive Needles

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01479569
Enrollment
5
Registered
2011-11-24
Start date
2011-11-08
Completion date
2017-02-17
Last updated
2018-02-14

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

Conditions

Cardiac Magnetic Resonance Imaging

Keywords

MRI Catheterization, Pericardiocentesis, MRI Safety, Cardiac Magnetic Resonance Imaging

Brief summary

Background: \- Pericardiocentesis uses a needle and small tube to drain fluid from space around the heart. The most common reason to perform this procedure is that the fluid is interfering with heart function. This procedure is usually guided by X-rays. However, researchers want to try the procedure using magnetic resonance imaging (MRI) instead of X-rays. MRI guidance may be more precise than X-rays, which can make the procedure easier and more effective. Objectives: \- To test whether MRI guidance can improve pericardiocentesis. Eligibility: \- Individuals at least 18 years of age who need to have pericardiocentesis. Design: * Participants will have a physical exam before the procedure. Blood samples will be taken. * The pericardiocentesis will be performed using MRI guidance. The procedure may take up to 2 hours. * If for some reason the MRI guidance is not successful, participants will have the regular X-ray procedure. The MRI system will be used to take high-quality pictures afterward to check the results....

Detailed description

Pericardiocentesis is a minimally invasive procedure to drain fluid from the pericardial space, created by the pericardial sac which cradles the heart. The most common reason to perform this procedure is that pericardial fluid is interfering with heart function. The next most common reason is to obtain pericardial fluid for testing to make a clinical diagnosis. Pericardiocentesis is performed using a long needle that may be guided by various means including blindly without imaging guidance, using electrocardiography electrodes to determine when the needle accidentally touches the heart, using echocardiography, using X-ray with- or without- contrast injections, or using a combination. Each has its advantages and limitations. We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization with tissue visualization but without X-ray radiation. When used to guide needle access to the pericardial space or from there even into heart cavities, MRI provides superb imaging guidance. What is especially valuable about MRI is that it provides the entire thoracic context of needle access, allowing the operator to avoid critical structures including the liver, lung, pleural space, and heart muscle. We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization in patients with tissue visualization but without X-ray radiation. We also have used these developments to guide needle access to the heart and pericardium in animal models. In this protocol we test the safety and feasibility of pericardiocentesis in adult patients, using commercially available MRI-compatible (passive) needles. If successful, this will enable more advanced minimally invasive procedures in adults and children.

Interventions

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: * Adult patients, age greater than or equal to 18 * Undergoing medically necessary diagnostic or therapeutic pericardiocentesis

Exclusion criteria

* Cardiogenic shock (sustained systolic blood pressure less than or equal to 80 mm Hg despite volume repletion on physical examination or requiring catecholamine support) * 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 frame
Reduce the pericardial effusion.

Secondary

MeasureTime frame
To test the feasibility of navigating passive needles percutaneously into the periocardial space using real-time MRI and MRI-compatible needles.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026