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

NCT ID: NCT05417464

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2024-03-21

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Management of conductive disorders after TAVR

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

Group Type: OTHER

Use of flowchart

Intervention Type: OTHER

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

Interventions

Use of flowchart

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Florence LECLERCQ, MD

Role: CONTACT

f-leclercq@chu-montpellier.fr

4 67 33 61 88 ext. 33

Facility Contacts

Florence LECLERCQ, MD

Role: primary

f-leclercq@chu-montpellier.fr

4 67 33 61 88 ext. 33

Other Identifiers

RECHMPL21_0646

Identifier Type: -

Identifier Source: org_study_id