NCT01672268

Brief Summary

This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

April 18, 2012

Last Update Submit

November 24, 2014

Conditions

Aortic Stenosis

Keywords

cardiac computed tomographyTranscatheter Aortic Valve Implantationsafety and efficacy

Outcome Measures

Primary Outcomes (1)

  • Composite end point

    Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography

    participants will be followed for the duration of 1 year

Secondary Outcomes (3)

  • To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

    inclusion visit

  • To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

    inclusion visit

  • To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

    inclusion visit

Study Arms (2)

Standard TAVI procedure

ACTIVE COMPARATOR

Patients without Cardiac CT measures before TAVI

Other: cardiac computed tomography

Cardiac CT scan before TAVI procedure

EXPERIMENTAL

patients with cardiac CT measures before TAVI

Other: cardiac computed tomography

Interventions

cardiac computed tomographyOTHER

cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy

Also known as: Transcatheter Aortic Valve Implantation
Cardiac CT scan before TAVI procedureStandard TAVI procedure

Eligibility Criteria

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

You may qualify if:

  • Patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. This patient will be selected for a TAVI. In this study, we only randomized patient for a TAVI with an Edwards prosthesis
  • male or female patient, older than eighteen years old
  • who have given their written consent
  • who are affiliated to the French social security system
  • which has a too high risk of surgical valvular replacement (EuroSCORE logistic \> 20% or Society of Thoracic Surgeons Score \> 10, or contre indicated to a cardiac surgery by a heart team
  • Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure

You may not qualify if:

  • Patient who can't give his written consent because of his physical or mental status
  • Adult patient protect by law (article L1121-8),
  • Person deprived of liberty (article L1121-8),
  • Pregnant women
  • Patient in terminal phase of illness,
  • Terminal kidney failure
  • Allergy to iodine
  • bicuspids ou unicuspid aortic,
  • Diameter of the left ventricular outflow tract \< 18mm or \> 25mm,
  • Diameter of the femoral artery \< 7mm, tortuosity or calcifications
  • Septal hypertrophy
  • Apical thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Grenoble, 38700, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Gilles MD BARONE ROCHETTE

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

August 24, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2014

Last Updated

November 25, 2014

Record last verified: 2012-04

Locations

FR(1)