Aortic Valve StenosisTAVICUNCT04335149
Follow-up After TAVR Without Systematic Intensive Care Unit Admission
An observational study of Aortic Valve Stenosis, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing TAVI for aortic valve stenosis from January 2017
Who may be able to join
- age > 18 yo
- Patients undergoing a TAVI at Montpellier University Hospital since 2017
- With implantation of a COREVALVE or EDWARDS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1- Year Follow-up After TAVR Performed Without Systematic Intensive Care Unit Admission
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:
Read more
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.
Read the 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
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic valve stenosis, TAVI
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of causes mortality
All cause mortality
Measured: 1 year
Description of causes heart failure
All cause heart failure
Measured: 1 year
Description of causes rehospitalisation
All cause rehospitalisation
Measured: 1 year
Secondary outcomes (1)
hospitalization duration
hospitalization duration
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Jan 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335149
- Sponsor's protocol ID
- RECHMPL20_0169
- Acronym
- TAVICU
- Status last verified
- May 2021
- First submitted
- 2 Apr 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1- Year Follow-up After TAVR Performed Without Systematic Intensive Care Unit Admission
- ClinicalTrials.gov ID
- NCT04335149
- Acronym / sponsor ID
- TAVICU / RECHMPL20_0169
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic valve stenosis, TAVI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing TAVI for aortic valve stenosis from January 2017
Key inclusion criteria (3 listed)
- age > 18 yo
- Patients undergoing a TAVI at Montpellier University Hospital since 2017
- With implantation of a COREVALVE or EDWARDS
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of causes mortality
Time frame: 1 year
All cause mortality
Description of causes heart failure
Time frame: 1 year
All cause heart failure
Description of causes rehospitalisation
Time frame: 1 year
All cause rehospitalisation
1 secondary outcome
hospitalization duration
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Leclercq, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of causes mortality (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.