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

NCT05103852 | Unknown

• 1 other identifier: 2017-A03145-48
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac MRI; Right Cardiac Catheterization

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in whom it is possible to collect all the hemodynamic data for right catheterization under MRI navigation

  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,%).

  24 hours

Study Arms (1)

Patients with right cardiac catheterization

EXPERIMENTAL

Procedure: Cardiac MRI

Interventions

Cardiac MRI PROCEDURE

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.

Patients with right cardiac catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hôpital Jacques Cartier

Massy, France

RECRUITING

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: December 13, 2018
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

FR (1)