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Magnetic Resonance Imaging for Cerebral Embolization During Minimal Invasive Mitral Valve Surgery

NCT02818166 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-08-04

No results posted yet for this study

Summary

The purpose of this study is to prospectively evaluate major and minor neurologic events in patients undergoing right mini-thoracotomy mitral valve surgery and to compare different aortic clamping techniques; specifically, the endoaortic balloon with retrograde perfusion (Endoreturn) and the transthoracic clamp with retrograde perfusion. Major neurologic events will be evaluate through standard neurologic evaluation; minor neurologic events will be evaluate through magnetic resonance (MR) assessment.

The first aim of the study is to determine the number and impact of microembolic events during right mini-thoracotomy mitral valve surgery on clinical neurological status and on MR evaluation. The investigators also aim to determine if different techniques of aortic clamping may impact on early outcome.

Study hypothesis: despite recent concerns arising about endoaortic balloon with retrograde perfusion, the investigators expect to show equivalence in term of safety and effectiveness of this technique compared with the transthoracic clamp in a selected population.

Conditions

  • Neurological Complications
  • Mitral Valve Insufficiency

Interventions

PROCEDURE

Mitral valve surgery

Right mini-thoracotomy mitral valve replacement/repair.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-06-30
Completion
2017-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02818166 on ClinicalTrials.gov