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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Valvular Heart Disease
• Intervention / Treatment: Other: Use of flowchart

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florence LECLERCQ, MD; Phone Number: 33 4 67 33 61 88; Email: f-leclercq@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital
    • Contact: Florence LECLERCQ, MD; Phone Number: 33 4 67 33 61 88; Email: f-leclercq@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Between inclusion and 1 month after TAVR procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Number of conductive disorders that lead to patient's rehospitalization	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	Between inclusion and 1 month after TAVR procedure
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): June 21, 2024
• Study Completion (Anticipated): July 21, 2024

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Intensive care; Aortic Valve,; Aortic Valve Stenosis,; Heart Valve Prosthesis Implantation,; Transcatheter Aortic Valve Replacement,; Telemetry,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: RECHMPL21_0646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No