Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow-up After TAVR Without Systematic Intensive Care Unit Admission (TAVICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335149
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease
Aortic Valve Stenosis

Detailed Description:

Since the first case described in 2002, indications of TAVI (transcatheter Aortic Valve Implantation) procedures increased in the treatment of symptomatic severe aortic stenosis. Initially reserved for inoperable patients or at high surgical risk, the indication for TAVI was recently extended to patients at intermediate surgical risk. Post-procedure intensive care admission (ICU) was initially considered the rule for all patients regarding the risk of high-grade conductive disorders, vascular or neurological complications. However, given the drastic reduction in serious complications and the increasing number of procedures, systematic ICU admission may be safely avoided. Selection criteria for ICU admission were established by our team in a previous study. The use of these low risk criteria, the growing experience of operators as well as technological improvements allow to safely avoid ICU admission in 1/3 of patients. However, long-term impact of this triage strategy remains unknown.

Objective:

The objective of this study is to assess 1-year outcomes of patients undergoing TAVI according to unit admission (ICU or conventional care unit (CCU)).

Methods This monocentric observational study retrospectively includes all patients undergoing TAVI at the Montpellier University Hospital from 2017. TAVI is indicated in patients with symptomatic severe aortic stenosis with a life expectancy > 1year and contra-indicated for conventional surgery, at high risk or intermediate surgical risk> 75 years after "heart team" decision. Exclusion criteria are patients who died before unit admission or referred a non-cardiological unit after the procedure. Two groups of patients are defined: (1) patients referred to the ICU and (2) patients referred to the CCU after the procedure according to risk-stratification criteria. Low-risk of complications criteria were defined as the absence of major comorbidities, hemodynamic stability, absence of pre-procedure right bundle branch block, LVEF> 40% and absence of procedural complications, particularly the absence of any new conductive disorder after 2 hours monitoring. The primary endpoint is 1-year major events (all-cause mortality, major cardiovascular event and rehospitalization for cardiac causes) according to the VARC-2 criteria. The secondary endpoints include hospitalization duration, 1-month major events and all-cause mortality during follow-up > 1 year depending on the group.

Data assessment Data on patients' baseline characteristics, procedural details and in-hospital outcomes is collected from a prospective TAVI database. No additional testing or biological samples were specifically required for this study

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 1- Year Follow-up After TAVR Performed Without Systematic Intensive Care Unit Admission
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Description of causes mortality [ Time Frame: 1 year ]
    All cause mortality

  2. Description of causes heart failure [ Time Frame: 1 year ]
    All cause heart failure

  3. Description of causes rehospitalisation [ Time Frame: 1 year ]
    All cause rehospitalisation


Secondary Outcome Measures :
  1. hospitalization duration [ Time Frame: 1 month ]
    hospitalization duration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing TAVI for aortic valve stenosis from January 2017
Criteria

Inclusion criteria:

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

Exclusion criteria:

  • 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

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): NCT04335149


Contacts
Layout table for location contacts
Contact: Florence Leclercq, MD, PhD 4.67.33.67.33 ext 33 f-leclercq@chu-montpellier.fr
Contact: Mariama Akodad, MD, PhD 46733250 ext 33 akodad@chu-montpellier.fr

Locations
Layout table for location information
France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Florence Leclercq, MD, PhD    04.67.33.67.33 ext 33    f-leclercq@chu-montpellier.fr   
Contact: Mariama Akodad, MD, PhD    46733250 ext 33    akodad@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Florence Leclercq, MD, PhD University Hospital, Montpellier
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04335149    
Other Study ID Numbers: RECHMPL20_0169
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Aortic valve stenosis
TAVI
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction