Valvular Heart DiseaseEVATAVINCT05417464
Evaluation and Validation of Management Strategy for Conductive Disorders After TAVR (EVATAVI)
A study testing Use of flowchart in people with Valvular Heart Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Use of flowchart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2023to 4 Oct 2024
- Phase
- Interventional
- 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
Who may be able to join
- Any patient who benefits from femoral TAVR regardless of the type of valve.
- Age ≥ 18 years old.
Who cannot join
- Patients who require CICU monitoring for a reason other than conduction disorders
- Patients with pacemaker or defibrillator
- Pregnant or breastfeeding women
- Patient refusing or unable to give consent: patient under guardianship or curator, mentally retarded, dementia, language barrier
- Patient not affiliated with an SS scheme
- Patient under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Validation of a Monitoring, Screening and Management Strategy for Conductive Disorders After TAVR (EVATAVI)
Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement).
While pacemaker implantation rate was about 10-15%, new onset LBBB (Left bundle branch block) was observed in 30 % of patients after TAVR but resolved at discharge in the majority of them, with less than 20% progressed to complete AV (atrioventricular) block requiring permanent pacing at hospital discharge.
Read more
Higher implantation and improvement of the devices were associated with decline of pace maker implantation rate over the years in experienced teams.
While guidelines do not give definite recommendation regarding conductive disorder management and pacemaker indication, a strategy of selective telemetry monitoring (TM) after TAVR according to the risk of conductive disorders may be proposed to limit indication and lenght of stay of intensive care unit admission (ICU), allowing direct admission of lower risk patients in general cardiology ward (GCW) without TM, to decrease the duration of TM when a conductive disorder is stable or regressive and finally to decrease the rate of pacemakers implantation.
Potential benefit may also include limitation of ICU overload in high volume TAVR centers, investigators can also expect shorter hospitalization duration, with potential economic impact, in line with the development of algorithms for fast track procedures.
Therefore the main objective of our prospective study was to evaluate feasibility and safety of a strategy of management of conductive disorders after TAVR based on an algorithm of diagnosis, monitoring and therapeutic strategies based on ECG analysis.
Read the detailed description
TAVR is now the reference method for the treatment of severe aortic stenosis in the elderly population. Regarding its good results, indications have recently been extended to younger, lower-risk patients. With the decrease in serious complications, severe conductive disorders requiring the implantation of a pacemaker have thus become the main complications of TAVR.
Despite the experience of operators and modified implantation techniques and in absence of specific recommendations, the rate of pacemaker implantation after a TAVR procedure levels off between 10% and 20% regardless of the prosthesis used and with highly variable rates depending on the center.
In the vast majoriy of cases, the conductive disorders only justify the monitoring of patients in ICU after the procedure,
However, majority of conductive disorders will be regressive or stable and will not justify a permanent pacemaker implantation. Furthemore, this systematic monitoring contributes to unnecessarily overcrowding of these medical structures.
Investigators thus put forward the hypothesis that by using a defined strategy for screening and monitoring conductive disorders occurring after a TAVR procedure, and by taking into account the recommendations on indication of definitive cardiac pacing, it would be possible to rationalize both the indications, the duration of monitoring (by telemetry/CICU or conventional sector) and the definitive pacemaker indication.
Investigators thus hope, thanks to this rationalized strategy, to reduce the indications and durations of monitoring by telemetry or CICU after a TAVR and to shorten the durations of overall hospitalization, but also to reduce the indication for permanent cardiac pacing without risk for the patient.
- Conditions
- Valvular Heart Disease
- Being tested
- Use of flowchart
- Keywords
- Aortic Valve,, Aortic Valve Stenosis,, Heart Valve Prosthesis Implantation,, Transcatheter Aortic Valve Replacement,, Telemetry,, Intensive care
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of flowchartOther
Use of flowchart for screening, monitoring and management of conductive disorders after TAVR
| Study group | Role | What they receive |
|---|---|---|
| Management of conductive disorders after TAVR | Other | Evaluation of efficacy and safety of a flowchart for screening, monitoring and management of conductive disorders after TAVR Receives: Other: Use of flowchart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a serious conductive disorder
Occurrence of a serious conductive disorder (one among the following : syncope, malaise, sudden death, heart failure) outside the CICU (whether the patient was there admitted initially or not)
Measured: Between inclusion and 1 month after TAVR procedure
Occurrence of a serious conductive disorder requiring specific management
Occurrence of a serious conductive disorder requiring specific management (one among the following : drug treatment, need for a transient or permanent pacemaker), outside the CICU (whether the patient was there admitted initially or not)
Measured: Between inclusion and 1 month after TAVR procedure
Secondary outcomes (10)
Incidence and type of conductive disorders requiring transfer to CICU (cardiac intensive care unit)
Measured: Between inclusion and 1 month after TAVR procedure
Pourcentage of Pacemaker implantation
Measured: Between inclusion and 1 month after TAVR procedure
Time of onset of conductive disorders requiring a pacemaker (immediate, hospital phase, after discharge from hospital)
Measured: Between inclusion and 1 month after TAVR procedure
Description of the evolution of conductive disorders that have not been the subject of pacemaker insertion (hospitalization)
Number of conductive disorders that lead to patient's rehospitalization
Measured: Between inclusion and 1 month after TAVR procedure
Description of the evolution of conductive disorders that have not been the subject of pacemaker insertion (death)
Number of conductive disorders that lead to patient's death
Measured: Between inclusion and 1 month after TAVR procedure
Death
Measured: Between inclusion and 1 month after TAVR procedure
Clinical status at one month (NYHA (New York Heart Association)
Measured: Between inclusion and 1 month after TAVR procedure
Death within the first month after TAVR
Measured: Between inclusion and 1 month after TAVR procedure
Duration of hospitalization in CICU
Measured: Between inclusion and 1 month after TAVR procedure
Duration of hospitalization in sector
Measured: Between inclusion and 1 month after TAVR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start21 Feb 2023
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a non-comparative prospective interventional study, involving the human category, which aims to evaluate the efficacy and safety of a flowchart for screening, monitoring and management of conductive disorders after TAVR
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417464
- Sponsor's protocol ID
- RECHMPL21_0646
- Acronym
- EVATAVI
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fournier A, Robert P, Lattuca B, Duflos C, Duroyon MM, Macia JC, Schmutz L, Steinecker M, Berdeu JM, Gandet T, Pasquie JL, Roubille F, Cayla G, Leclercq F. A Streamline Strategy for Indication and Length of Telemetry Monitoring After TAVR. Catheter Cardiovasc Interv. 2026 Jan;107(1):142-152. doi: 10.1002/ccd.70299. Epub 2025 Nov 5.
PubMed 41194410
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Validation of a Monitoring, Screening and Management Strategy for Conductive Disorders After TAVR (EVATAVI)
- ClinicalTrials.gov ID
- NCT05417464
- Acronym / sponsor ID
- EVATAVI / RECHMPL21_0646
- Conditions
- Valvular Heart Disease
- Keywords
- Aortic Valve,, Aortic Valve Stenosis,, Heart Valve Prosthesis Implantation,, Transcatheter Aortic Valve Replacement,, Telemetry,, Intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 14 Jun 2022 (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.
Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement).
While pacemaker implantation rate was about 10-15%, new onset LBBB (Left bundle branch block) was observed in 30 % of patients after TAVR but resolved at discharge in the majority of them, with less than 20% progressed to complete AV (atrioventricular) block requiring permanent pacing at hospital discharge.
Higher implantation and improvement of the devices were associated with decline of pace maker implantation rate over the years in experienced teams.
While guidelines do not give definite recommendation regarding conductive disorder management and pacemaker indication, a strategy of selective telemetry monitoring (TM) after TAVR according to the risk of conductive disorders may be proposed to limit indication and lenght of stay of intensive care unit admission (ICU), allowing direct admission of lower risk patients in general cardiology ward (GCW) without TM, to decrease the duration of TM when a conductive disorder is stable or regressive and finally to decrease the rate of pacemakers implantation.
Potential benefit may also include limitation of ICU overload in high volume TAVR centers, investigators can also expect shorter hospitalization duration, with potential economic impact, in line with the development of algorithms for fast track procedures.
Therefore the main objective of our prospective study was to evaluate feasibility and safety of a strategy of management of conductive disorders after TAVR based on an algorithm of diagnosis, monitoring and therapeutic strategies based on ECG analysis.
Detailed description
TAVR is now the reference method for the treatment of severe aortic stenosis in the elderly population. Regarding its good results, indications have recently been extended to younger, lower-risk patients. With the decrease in serious complications, severe conductive disorders requiring the implantation of a pacemaker have thus become the main complications of TAVR.
Despite the experience of operators and modified implantation techniques and in absence of specific recommendations, the rate of pacemaker implantation after a TAVR procedure levels off between 10% and 20% regardless of the prosthesis used and with highly variable rates depending on the center.
In the vast majoriy of cases, the conductive disorders only justify the monitoring of patients in ICU after the procedure,
However, majority of conductive disorders will be regressive or stable and will not justify a permanent pacemaker implantation. Furthemore, this systematic monitoring contributes to unnecessarily overcrowding of these medical structures.
Investigators thus put forward the hypothesis that by using a defined strategy for screening and monitoring conductive disorders occurring after a TAVR procedure, and by taking into account the recommendations on indication of definitive cardiac pacing, it would be possible to rationalize both the indications, the duration of monitoring (by telemetry/CICU or conventional sector) and the definitive pacemaker indication.
Investigators thus hope, thanks to this rationalized strategy, to reduce the indications and durations of monitoring by telemetry or CICU after a TAVR and to shorten the durations of overall hospitalization, but also to reduce the indication for permanent cardiac pacing without risk for the patient.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-comparative prospective interventional study, involving the human category, which aims to evaluate the efficacy and safety of a flowchart for screening, monitoring and management of conductive disorders after TAVR
| Arm | Type | Receives |
|---|---|---|
| Management of conductive disorders after TAVR | Other | Other: Use of flowchartEvaluation of efficacy and safety of a flowchart for screening, monitoring and management of conductive disorders after TAVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient who benefits from femoral TAVR regardless of the type of valve.
- Age ≥ 18 years old.
Key exclusion criteria (6 listed)
- Patients who require CICU monitoring for a reason other than conduction disorders
- Patients with pacemaker or defibrillator
- Pregnant or breastfeeding women
- Patient refusing or unable to give consent: patient under guardianship or curator, mentally retarded, dementia, language barrier
- Patient not affiliated with an SS scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of flowchartUse of flowchart for screening, monitoring and management of conductive disorders after TAVR | Other | Management of conductive disorders after TAVR |
Primary outcome
Occurrence of a serious conductive disorder
Time frame: Between inclusion and 1 month after TAVR procedure
Occurrence of a serious conductive disorder (one among the following : syncope, malaise, sudden death, heart failure) outside the CICU (whether the patient was there admitted initially or not)
Occurrence of a serious conductive disorder requiring specific management
Time frame: Between inclusion and 1 month after TAVR procedure
Occurrence of a serious conductive disorder requiring specific management (one among the following : drug treatment, need for a transient or permanent pacemaker), outside the CICU (whether the patient was there admitted initially or not)
10 secondary outcomes
Incidence and type of conductive disorders requiring transfer to CICU (cardiac intensive care unit)
Time frame: Between inclusion and 1 month after TAVR procedure
Pourcentage of Pacemaker implantation
Time frame: Between inclusion and 1 month after TAVR procedure
Time of onset of conductive disorders requiring a pacemaker (immediate, hospital phase, after discharge from hospital)
Time frame: Between inclusion and 1 month after TAVR procedure
Description of the evolution of conductive disorders that have not been the subject of pacemaker insertion (hospitalization)
Time frame: Between inclusion and 1 month after TAVR procedure
Description of the evolution of conductive disorders that have not been the subject of pacemaker insertion (death)
Time frame: Between inclusion and 1 month after TAVR procedure
Death
Time frame: Between inclusion and 1 month after TAVR procedure
Clinical status at one month (NYHA (New York Heart Association)
Time frame: Between inclusion and 1 month after TAVR procedure
Death within the first month after TAVR
Time frame: Between inclusion and 1 month after TAVR procedure
Duration of hospitalization in CICU
Time frame: Between inclusion and 1 month after TAVR procedure
Duration of hospitalization in sector
Time frame: Between inclusion and 1 month after TAVR procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 41194410Fournier A, Robert P, Lattuca B, Duflos C, Duroyon MM, Macia JC, Schmutz L, Steinecker M, Berdeu JM, Gandet T, Pasquie JL, Roubille F, Cayla G, Leclercq F. A Streamline Strategy for Indication and Length of Telemetry Monitoring After TAVR. Catheter Cardiovasc Interv. 2026 Jan;107(1):142-152. doi: 10.1002/ccd.70299. Epub 2025 Nov 5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of flowchart in people with Valvular Heart Disease, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of a serious conductive disorder (time frame: Between inclusion and 1 month after TAVR procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05417464, which also lists 1 linked publication.
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 12 Jun 2026.