Evaluation and Validation of Management Strategy for Conductive Disorders After TAVR (EVATAVI)
Key facts
- Who runs it
- University Hospital, Montpellier
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 250 people enrolled
- Started
- 21 Feb 2023
- Ended
- 4 Oct 2024
- Type of study
- Interventional
- Treatments tested
- Use of flowchart
- Record updated
- 12 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Any patient who benefits from femoral TAVR regardless of the type of valve
- Age ≥ 18 years old
Who cannot take part
- Patients who require CICU monitoring for a reason other than conduction disorders
- Patient refusing or unable to give consent: patient under guardianship or curator, mentally retarded, dementia, language barrier
- Patients with pacemaker or defibrillator
- Pregnant or breastfeeding women
- Patient not affiliated with an SS scheme
- Patient under judicial protection
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement).
Read full original descriptionShow less
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.
The group in the trial
- Management of conductive disorders after TAVROther group
Evaluation of efficacy and safety of a flowchart for screening, monitoring and management of conductive disorders after TAVR
Treatment: Use of flowchart
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation and Validation of a Monitoring, Screening and Management Strategy for Conductive Disorders After TAVR (EVATAVI)
- Record updated
- 12 June 2026