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Image Fusion and Calcification Raising in Trans Aortic Valve Implantation (TAVI)

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ClinicalTrials.gov Identifier: NCT03247465
Recruitment Status : Unknown
Verified July 2017 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve implantation (TAVI) has been developed since 2002, first to treat rejected patients from conventional surgery, then to treat high surgical risk patients and nowadays probably intermediate surgical risk patient. TAVI related complications are still recurrent and the investigators are searching a way to decrease them.

One of them could be image fusion, since it may decrease radiation exposure and contrast agent use. It may also improve valve placement position leading to decreased complications.

40 prospective and consecutive patients will be included. Participants will be divided into two groups: the 20 first included will be control group, the 20 following patients will be the fusion group. For control group TAVI procedure will be the usual one, for fusion group the procedure will be the usual one with addition of computed tomography 3D images fusion with fluoroscopy 2D images.

Main evaluation criteria will be radiation exposure, measured by dose area product (DAP). Secondary evaluation criterion will be procedural as contrast agent volume used, procedure duration, subjective usefulness of image fusion or procedure failure evaluated immediately after procedure. The investigators will also evaluated procedure induced complications as de novo pacemaker implantation, de novo left bundle branch, vascular complication, major bleeding, acute kidney failure, significant aortic regurgitation. These complications occurrence will be evaluated after 1 month follow up, during the usual following consultation.


Condition or disease Intervention/treatment Phase
Symptomatic Aortic Stenosis Other: Image Fusion Not Applicable

Detailed Description:

Aortic stenosis is one of the most common cardiology diseases. If untreated, symptomatic aortic stenosis rapidly leads to death. Most of the time, this disease affects old fragile people for whom conventional surgery is countered or very risky. That is why Trans aortic valve implantation has been developed since 2002, first to treat rejected patients from conventional surgery, then to treat high surgical risk patients and nowadays probably intermediate surgical risk patient. Indeed, thanks to prodigious technical and human progress, procedure induced complication have clearly decreased. But TAVI related complications are still recurrent and the investigators are searching a way to decrease them.

One of them could be image fusion, since it may decrease radiation exposure and contrast agent use correlated to acute kidney failure. It may also improve valve placement position, and the investigators know that many rhythmic (atrio-ventricular block) and valvular (significant aortic regurgitation) complications are partially due to placement mistakes. So the investigators hope that image fusion will decrease these complications.

The investigators will include 40 prospective and consecutive patients. Inclusion criterion will be all major patients admitted in Nantes CHU for transfemoral aortic valve replacement with SAPIEN® 3 valve. Exclusion criterion will be women of childbearing age without contraception, impossible written consent, judiciary protected people. After inclusion, patients will be divided into two groups: the 20 first included will be control group, the 20 following patients will be the fusion group. For control group TAVI procedure will be the usual one, for fusion group the procedure will be the usual one with addition of computed tomography 3D images fusion with fluoroscopy 2D images. The only difference during all patient medical care will be the addition of image fusion in fusion group. Before and after procedure, both groups will have the usual medical monitoring and the appropriated medical interventions to participants case.

Main evaluation criterion will be radiation exposure, measured by dose area product (DAP).

Secondary evaluation criterion will be procedural as:

  • contrast agent volume used (mL),
  • procedure duration (min),
  • subjective usefulness of image fusion evaluated on a 0 to 3 scale
  • procedure failure : death, more than one valve implantation, valve dysfunction (mean trans-valvular gradient > 20 mmHg or moderate to severe aortic regurgitation) These criterions will be evaluated immediately after procedure.

The investigators will also evaluated procedure induced complications as:

  • de novo pacemaker implantation
  • de novo left bundle branch
  • non minor vascular complication on VARC-2 definition
  • major bleeding (BARC 3 or 5)
  • acute kidney failure (AKIN 2 or 3)
  • significant aortic regurgitation ≥ 2/4 These complications occurrence will be evaluated after 1 month follow up, during the usual following consultation with echocardiography.

Then differences between will be tested with appropriated statistical methods.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The 20 first included patients will be control group, the 20 following patients will be the fusion group.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Value of Fusion of 3D Images With 2D Images, Associated With Calcification Raising During Trans Aortic Valve Implantation Procedures
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: Group "Fusion"
Trans aortic valve replacement with usual procedure with the addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.
Other: Image Fusion
Addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.

No Intervention: Group "Control"
Trans aortic valve replacement with usual procedure



Primary Outcome Measures :
  1. Radiation exposure [ Time Frame: Immediately post procedure ]
    Dose area product (cGy/cm2)


Secondary Outcome Measures :
  1. Contrast product [ Time Frame: Immediately post procedure ]
    Contrast volume (mL) used during procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted in Nantes CHU for trans fermoral aortic valve replacement with SAPIEN 3® device
  • Patient who accepted to participate to the study

Exclusion Criteria:

  • Impossible written consent
  • Judiciary protected people
  • Minor
  • Women of childbearing age without contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247465


Contacts
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Contact: Patrice Guerin, Pr 0240165592 patrice.guerin@chu-nantes.fr
Contact: Mickaël Bonin mickael.bonin44@gmail.com

Locations
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France
Nantes University Hospital Not yet recruiting
Nantes, France, 44093
Contact: Patrice Guerin, Pr    0240165592    patrice.guerin@chu-nantes.fr   
Principal Investigator: Patrice Guerin, Pr         
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03247465     History of Changes
Other Study ID Numbers: RC17_0114
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Calcinosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Calcium Metabolism Disorders
Metabolic Diseases