TAVR Without Predilatation (TAVIWOP)

Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study

The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Procedure: Transcatheter aortic valve implantation required for symptomatic aortic stenosis

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all comers patients undergoing TAVR using transfemoral or transcaorotid approaches

Description

Inclusion criteria:

- patients undergoing TAVR via transfemoral or rascoarotid access

Exclusion criteria:

- others access (subclavian, apical, transaortic)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

TAVR; all comers study including all transfemoral or transcarotid TAVR procédures. direct implantation is the default strategy usually used in our enter as in may centers

Procedure: Transcatheter aortic valve implantation required for symptomatic aortic stenosis; The procedure is performed via transfemoral or transcarotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success of the direct implantation	success of the direct implantation defined as failure of crossing with the THV after 3 attemps and absence of complication related to the direct crossing	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indidence of post dilatation	Indidence of post dilatation	1 day
Underexpansion of the Edwards SAPIEN 3 THV	Underexpansion of the Edwards SAPIEN 3 THV	1 day
risks factors of failure of crossing	risks factors of failure of crossing : femoral vs carotid access, type of THV , vascular tortuosities, biscuipid valve, calcification, tight stenosis, horizontal aorta, small annulus	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Florence Leclercq, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: TAVR; Balloon prediltation; success of crossing the valve; direct implanation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: RECHMPL20_0204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No