Evaluation and Validation of Management Strategy for Conductive Disorders After TAVR (EVATAVI)

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05417464

Collaborator

(none)

250

Enrollment

Location

Arm

22.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Valvular Heart Disease	Other: Use of flowchart	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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 TAVRThis 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)

Primary Purpose:

Other

Official Title:

Evaluation and Validation of a Monitoring, Screening and Management Strategy for Conductive Disorders After TAVR (EVATAVI)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 21, 2024

Anticipated Study Completion Date :

Jul 21, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Management of conductive disorders after TAVR Evaluation of efficacy and safety of a flowchart for screening, monitoring and management of conductive disorders after TAVR	Other: Use of flowchart Use of flowchart for screening, monitoring and management of conductive disorders after TAVR

Arm

Intervention/Treatment

Other: Management of conductive disorders after TAVR

Evaluation of efficacy and safety of a flowchart for screening, monitoring and management of conductive disorders after TAVR

Other: Use of flowchart

Use of flowchart for screening, monitoring and management of conductive disorders after TAVR

Outcome Measures

Primary Outcome Measures

Occurrence of a serious conductive disorder [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 [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)

Secondary Outcome Measures

Incidence and type of conductive disorders requiring transfer to CICU (cardiac intensive care unit) [Between inclusion and 1 month after TAVR procedure]
Pourcentage of Pacemaker implantation [Between inclusion and 1 month after TAVR procedure]
Time of onset of conductive disorders requiring a pacemaker (immediate, hospital phase, after discharge from hospital) [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) [Between inclusion and 1 month after TAVR procedure]
Number of conductive disorders that lead to patient's rehospitalization
Description of the evolution of conductive disorders that have not been the subject of pacemaker insertion (death) [Between inclusion and 1 month after TAVR procedure]
Number of conductive disorders that lead to patient's death
Death [Between inclusion and 1 month after TAVR procedure]
Clinical status at one month (NYHA (New York Heart Association) [Between inclusion and 1 month after TAVR procedure]
Death within the first month after TAVR [Between inclusion and 1 month after TAVR procedure]
Duration of hospitalization in CICU [Between inclusion and 1 month after TAVR procedure]
Duration of hospitalization in sector [Between inclusion and 1 month after TAVR procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any patient who benefits from femoral TAVR regardless of the type of valve.
Age ≥ 18 years old.

Exclusion Criteria:

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