Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI (CT-TAVI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01672268
First received: April 18, 2012
Last updated: August 21, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Aortic Stenosis
Other: cardiac computed tomography
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Composite end point [ Time Frame: participants will be followed for the duration of 1 year ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • To compare results of transthoracic / transoesophageal echocardiography and cardiac CT [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]
    • Size of the aortic annulus/ diameter and area

  • To compare results of transthoracic / transoesophageal echocardiography and cardiac CT [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]
    • Left ventricular outflow tract, anatomy of the aortic roots

  • To compare results of transthoracic / transoesophageal echocardiography and cardiac CT [ Time Frame: inclusion visit ] [ Designated as safety issue: No ]
    • Left ventricular function, size, volume


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard TAVI procedure
Patients without Cardiac CT measures before TAVI
Other: cardiac computed tomography
cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy
Other Name: Transcatheter Aortic Valve Implantation
Experimental: Cardiac CT scan before TAVI procedure
patients with cardiac CT measures before TAVI
Other: cardiac computed tomography
cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy
Other Name: Transcatheter Aortic Valve Implantation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672268

Contacts
Contact: Gilles BARONE ROCHETTE, MD (33+) 476768480 GBarone@chu-grenoble.fr
Contact: Estelle VAUTRIN, MD (33+) 476768480 EVautrin@chu-grenoble.fr

Locations
France
University Hospital Recruiting
Grenoble, France, 38700
Sub-Investigator: Estelle VAUTRIN         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Gilles MD BARONE ROCHETTE University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01672268     History of Changes
Other Study ID Numbers: 2011-A001113-38, 2011-A001113-38
Study First Received: April 18, 2012
Last Updated: August 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
cardiac computed tomography
Transcatheter Aortic Valve Implantation
safety and efficacy

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on August 01, 2014