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

NCT05417464 | Unknown

• 1 other identifier: RECHMPL21_0646
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvular Heart Disease

Keywords

Aortic Valve,; Aortic Valve Stenosis,; Heart Valve Prosthesis Implantation,; Transcatheter Aortic Valve Replacement,; Telemetry,; Intensive care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

• 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

Study Arms (1)

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

Other: Use of flowchart

Interventions

Use of flowchart OTHER

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

Management of conductive disorders after TAVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Central Study Contacts

Florence LECLERCQ, MD

CONTACT

4 67 33 61 88; f-leclercq@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 14, 2022
• Study Start: February 21, 2023
• Primary Completion: February 21, 2024
• Study Completion: March 21, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

FR (1)