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Completed

NCT Number: NCT01672268

Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital

Grenoble, 38700, France

About this study

The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

cardiac computed tomography

Other

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

Other names: Transcatheter Aortic Valve Implantation

Primary outcomes

  1. Composite end point

    Time frame: participants will be followed for the duration of 1 year

    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

Secondary outcomes

  1. To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

    Time frame: inclusion visit

    • Size of the aortic annulus/ diameter and area
  2. To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

    Time frame: inclusion visit

    • Left ventricular outflow tract, anatomy of the aortic roots
  3. To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

    Time frame: inclusion visit

    • Left ventricular function, size, volume

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)

Acronym: CT-TAVI

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Aug 24, 2012
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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