NCT02818166

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

January 5, 2016

Last Update Submit

August 2, 2016

Conditions

Neurological ComplicationsMitral Valve Insufficiency

Keywords

magnetic resonanceright mini-thoracotomy

Outcome Measures

Primary Outcomes (2)

  • MR microembolization

    To determine the incidence of new lesions on pre-discharge MR in patients undergoing right mini-thoracotomy mitral valve surgery according to different aortic clamping techniques.

    untill 3 days after surgical procedure

  • Clinical events and MR outcome correlation

    To assess the correlation between clinical neurological peri-procedural events (TIA, Stroke), cognitive / neuropsychological status and the occurrence of new lesions on pre-discharge MR.

    untill 3 days after surgical procedure

Secondary Outcomes (1)

  • Evolution of MR lesions

    3 month follow up

Study Arms (2)

Endoaortic Clamp

EXPERIMENTAL

Right mini-thoracotomy mitral valve surgery with retrograde perfusion and endoaortic balloon clamp

Procedure: Mitral valve surgery

Transthoracic Clamp

ACTIVE COMPARATOR

Right mini-thoracotomy mitral valve surgery with retrograde perfusion and transthoracic clamp.

Procedure: Mitral valve surgery

Interventions

Mitral valve surgeryPROCEDURE

Right mini-thoracotomy mitral valve replacement/repair.

Endoaortic ClampTransthoracic Clamp

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years.
  • Indication for elective mitral valve surgery +/- tricuspid valve surgery through right mini-thoracotomy.
  • No contraindication for MR

You may not qualify if:

  • Neuro-cognitive diseases;
  • Peripheral vascular disease;
  • Atrial fibrillation;
  • PFO o interatrial defect;
  • Previous Stroke;
  • Autoimmune diseases;
  • Neoplastic diseases;
  • Migraine;
  • Celiac disease;
  • Alchool or drug abuse;
  • Contraindication for MR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin - Cardiothoracic Department

Turin, Italy, 10126, Italy

RECRUITING

Related Publications (1)

  • Barbero C, Ricci D, Cura Stura E, Pellegrini A, Marchetto G, ElQarra S, Boffini M, Passera R, Valentini MC, Rinaldi M. Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):76. doi: 10.1186/s13063-017-1821-y.

    PMID: 28222779DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Cristina Barbero, MD

CONTACT

+390116335511cristina.barbero@unito.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiothoracic Surgeon

Study Record Dates

First Submitted

January 5, 2016

First Posted

June 29, 2016

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

IT(1)