Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.
NCT ID: NCT05103852
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2018-12-13
2021-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with right cardiac catheterization
Cardiac MRI
vigilant patient installed in the MRI with compatible ECG electrodes for synchronization and monitoring, blood pressure cuff for monitoring, cardiac antenna. Sterile drape over the femoral region, femoral local anesthesia, femoral venipuncture, Swan Ganz probe venous navigation (CE marking, MRI compatible at 1.5T) with balloon inflated with 2 cc of gadolinium, navigation under real time SSFP cine sequence.
Interventions
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Cardiac MRI
vigilant patient installed in the MRI with compatible ECG electrodes for synchronization and monitoring, blood pressure cuff for monitoring, cardiac antenna. Sterile drape over the femoral region, femoral local anesthesia, femoral venipuncture, Swan Ganz probe venous navigation (CE marking, MRI compatible at 1.5T) with balloon inflated with 2 cc of gadolinium, navigation under real time SSFP cine sequence.
Eligibility Criteria
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Inclusion Criteria
* Having an indication for a diagnostic of right cardiac catheterization at the J Cartier Hospital for one of the following pathologies: dilated, restrictive cardiomyopathy, pulmonary arterial hypertension, chronic constrictive pericarditis, chronic post-embolic pulmonary heart.
* Subject affiliated or beneficiary of a social security scheme
* Patient having freely signed the informed consent.
Exclusion Criteria
* Presence of a contraindication to MRI: intraocular metallic splinter, surgical clip for cerebral aneurysm, claustrophobia, defibrillator, implanted electronic equipment) or to gadolinium chelates (anaphylactic reactions to gadolinium chelates, creatinine clearance \<= 30 ml / min).
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
* Patient participating in another clinical study
18 Years
ALL
No
Sponsors
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European Clinical Trial Experts Network
OTHER
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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Hôpital Jacques Cartier
Massy, , France
Countries
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Central Contacts
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Facility Contacts
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Jérôme GAROT, Dr
Role: primary
Other Identifiers
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2017-A03145-48
Identifier Type: -
Identifier Source: org_study_id