Image Fusion and Calcification Raising in Trans Aortic Valve Implantation

NCT03247465 | Withdrawn

• 1 other identifier: RC17_0114
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Radiation exposure

  Dose area product (cGy/cm2)

  Immediately post procedure

Secondary Outcomes (1)

• Contrast product

  Immediately post procedure

Study Arms (2)

Group "Fusion"

EXPERIMENTAL

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

Group "Control"

NO INTERVENTION

Trans aortic valve replacement with usual procedure

Interventions

Image Fusion OTHER

Addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.

Group "Fusion"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The 20 first included patients will be control group, the 20 following patients will be the fusion group.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 11, 2017
• Study Start: September 13, 2017
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)