One Year Pacing Dependency After TAVR

Recruiting

• Conditions: Patients Above 18 Years; Patient Discharge; Pacing Therapy; Aortic Stenosis (Treated With TAVI)

• Registration Number: NCT06756282
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and two-thirds of patients who required a permanent pace maker implantation post TAVR were not found to be dependent at subsequent follow-up. This study aims to evaluate a cohort of patients permanently implanted with a pacemaker post-TAVR for high-grade conductive disorders and to describe the prevalence of effective pacemaker stimulation at 1 year follow-up. Secondary objectives include the evaluation of the prevalence of effective stimulation 3 months after implantation of the pace maker , description of the types of conductive disorders associated with atrial and/or ventricular stimulation, description of the initial indication for pacemaker implantation, description of the characteristics of the population with or without stimulation dependency. The objective is to better rationalize indication of permanent stimulation after TAVI

Detailed Description

A number of independent predictors have been found for long-term pacemaker dependence after TAVR that included a pre-existing RBBB, first-degree atrioventricular block, left anterior hemiblock, porcelain aorta, and implantation depth of the prosthesis However, indications for definitive cardiac stimulation after TAVR remain controversial excepted in case of complete or persistent high-grade BAV. The recommendations are particularly imprecise regarding intraventricular conductive disorders (LBBB++) and AVB 1.

Regarding the potential occurrence of more serious and delayed conductive disorders, the implantation of a pacemaker can sometimes be proposed to limit the duration of hospitalization in intensive care or ECG monitoring. The pacemaker implantation rate therefore probably does not reflect the true incidence of high-grade conductive disorders after TAVI because this rate varies greatly depending on the center, the indications for definitive stimulation still remain unclear, the rapid implantation times for a conductive disorder which risks getting worse (LBBG++) in a context of ever-shorter hospitalization periods can artificially increase the number of implantations.

the main objective of our study is therefore to evaluate a cohort of patients permanently implanted post-TAVR in our center since September 2023 for high-grade conductive disorders and to describe the prevalence of effective pacemaker stimulation at 1 year follow-up. Secondary objectives include the prevalence of effective stimulation 3 months after implantation of the definitive pace maker , description of the types of conductive disorders associated with pacing dependency at follow-up, description of the initial indication for pacemaker implantation, description of the characteristics of the population with or without stimulation dependency Describe serious clinical events at 3 months and 12 months (mortality, stroke, heart failure, rehospitalization for cardiac causes, complications related to the pace maker) Describe the profile of stimulation or non-stimulus dependent patients

Study Timeline

• Study Start: 2024-11-13
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Status Verified: 2025-01
• Study First Posted: 2025-01-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-10
• Study Completion: 2027-10-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

all patients who need a permanent pacemaker implantation after TAVR

Exclusion Criteria

Patients who have already a pace maker before TAVR

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pacing dependency at 1 year follow-up	6 months	pacing dependency is defined: 1. escape QRS rhythm \< 30 bpm; 2. High degree atrioventricular block (paroxysmal or permanent); 3. Atrial fibrillation with escape rhythm \<40/min

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, France