Follow-up After TAVR Without Systematic Intensive Care Unit Admission

NCT04335149 | Unknown

• 1 other identifier: RECHMPL20_0169
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Since the first case described in 2002, TAVI (transcatheter Aortic Valve Implantation) revolutionized the management of severe symptomatic aortic stenosis. Initially reserved for patients with prohibitive surgical risk, transfemoral TAVI in now indicated according to European Guidelines for patients at intermediate surgical risk and those \> 75 ans. Post-procedure intensive care admission (ICU), initially considered as the rule regarding the risk of complications, (particularly conductive disorders), may be avoided in 1/3 of patients regarding drastic reduction in serious complications and growing experience of operators as the investigator shown in a previous prospective study. Predictive criteria for low-risk of complications were therefore established by our team and may be used in routine to select patients that might avoid ICU. However, long-term impact of this triage strategy remains unknown. Objective: The objective of this study is to assess 1-year outcomes according to unit admission selection (ICU or conventional care unit (CCU)) in patients undergoing TAVI. Since the first case described in 2002, TAVI (transcatheter Aortic Valve Implantation) revolutionized the management of severe symptomatic aortic stenosis. Initially reserved for patients with prohibitive surgical risk, transfemoral TAVI in now indicated according to European Guidelines for patients at intermediate surgical risk and those \> 75 ans. Post-procedure intensive care admission (ICU), initially considered as the rule regarding the risk of complications, (particularly conductive disorders), may be avoided in 1/3 of patients regarding drastic reduction in serious complications and growing experience of operators as the investigator shown in a previous prospective study. Predictive criteria for low-risk of complications were therefore established by our team and may be used in routine to select patients that might avoid ICU. However, long-term impact of this triage strategy remains unknown. Objective: The objective of this study is to assess 1-year outcomes according to unit admission selection (ICU or conventional care unit (CCU)) in patients undergoing TAVI.

Conditions

Aortic Valve Stenosis

Keywords

Aortic valve stenosis; TAVI

Outcome Measures

Primary Outcomes (3)

• Description of causes mortality

  All cause mortality

  1 year

• Description of causes heart failure

  All cause heart failure

  1 year

• Description of causes rehospitalisation

  All cause rehospitalisation

  1 year

Secondary Outcomes (1)

• hospitalization duration

  1 month

Study Arms (2)

COREVALVE

Patients undergoing a TAVI at Montpellier University Hospital since 2017 with implantation of a COREVALVE

EDWARDS

Patients undergoing a TAVI at Montpellier University Hospital since 2017 with implantation of a EDWARDS

Eligibility Criteria

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

Study Population

Patients undergoing TAVI for aortic valve stenosis from January 2017

You may qualify if:

• age \> 18 yo
• Patients undergoing a TAVI at Montpellier University Hospital since 2017
• With implantation of a COREVALVE or EDWARDS

You may not qualify if:

• Minor patient
• Patient unable to give consent for reasons of understanding or language barrier
• Death before unit admission
• Patients referred to a non cardiological unit after the procedure

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Florence Leclercq, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

FR (1)