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Follow-up After TAVR Without Systematic Intensive Care Unit Admission

NCT04335149 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2021-05-06

No results posted yet for this study

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Florence Leclercq, MD, PhD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-12-01
Completion
2022-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335149 on ClinicalTrials.gov