NCT02308566

Brief Summary

In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation technique. The detection of cerebral emboli is performed not-invasively by transcranial Doppler detection of high-intensity transient signals representing solid or gaseous microembolism in the middle cerebral arteries. The investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism during aortic valve surgery using extracorporeal circulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

4.8 years

First QC Date

December 2, 2014

Last Update Submit

June 29, 2016

Conditions

Aortic Valve StenosisExtracorporeal Circulation

Keywords

Intracranial EmbolismUltrasonography, Doppler, Transcranial

Outcome Measures

Primary Outcomes (1)

  • Total and interval-related cerebral microembolic load as measured by transcranial Doppler

    Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)

Secondary Outcomes (7)

  • Cerebral complications, e.g. delirium and stroke as detected clinically

    In-hospital period (until hospital discharge, duration approx. 7-10 days)

  • Redo surgery

    In-hospital period (until hospital discharge, duration approx. 7-10 days)

  • ICU length of stay

    In-hospital period (until hospital discharge, duration approx. 7-10 days)

  • Extubation time

    In-hospital period (until hospital discharge, duration approx. 7-10 days)

  • Thromboembolic complications

    In-hospital period (until hospital discharge, duration approx. 7-10 days)

  • +2 more secondary outcomes

Study Arms (2)

Conventional Extracorporeal Circulation Technique

ACTIVE COMPARATOR

Conventional Extracorporeal Circulation Technique

Procedure: Conventional Extracorporeal Circulation (CECC)

Minimized Extracorporeal Circulation Technique

EXPERIMENTAL

Minimized Extracorporeal Circulation Technique

Procedure: Minimized Extracorporeal Circulation (MECC)

Interventions

Minimized Extracorporeal Circulation (MECC)PROCEDURE

This group of patients receives surgical aortic valve replacement using MECC.

Minimized Extracorporeal Circulation Technique
Conventional Extracorporeal Circulation (CECC)PROCEDURE

This group of patients receives surgical aortic valve replacement using CECC.

Conventional Extracorporeal Circulation Technique

Eligibility Criteria

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

You may qualify if:

  • Isolated Severe Aortic Valve Stenosis
  • No other cardiac disease
  • No other coronary heart disease
  • Written informed consent

You may not qualify if:

  • Double valve surgery
  • Concomitant coronary artery bypass surgery
  • Vascular surgery
  • Age \< 18 yrs.
  • Age \> 80 yrs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve StenosisIntracranial Embolism

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionIntracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesThromboembolismEmbolism and Thrombosis

Study Officials

  • Thierry Carrel, MD, PhD

    Department of Cardiovascular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 4, 2014

Study Start

June 1, 2011

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06

Locations

CH(1)