Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.

Not Applicable

• Conditions: Right Cardiac Catheterization; Cardiac MRI
• Interventions: Procedure: Cardiac MRI

• Registration Number: NCT05103852
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-13
• Primary Completion: 2019-12-13
• Status Verified: 2021-10
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-11-02
• Last Update Posted: 2021-11-02
• Study Completion: 2021-12-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patient over 18 years old
• 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

• Pregnancy (declarative, known pregnancy, any unexplained period delay in a woman of childbearing age)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with right cardiac catheterization	Cardiac MRI	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation	24 hours	Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation, as well as all the anatomical, functional, flow and substrate determination data by magnetic resonance (N / 35,%).

Trial Locations

Locations (1)

Hôpital Jacques Cartier; 🇫🇷 Massy, France