Clinical trial NCT06756282: One Year Pacing Dependency After TAVR
Official title: Pacing Dependence at 1 Year Follow-up in Patients Implanted With a Pacemaker After TAVR: a Multicenter Observational Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients Above 18 Years
Patient Discharge
Pacing Therapy
Aortic Stenosis (Treated With TAVI)
Keywords: transcatheter aortic valve replacement (TAVR)
permanent pacing
conductive disorders
pacing dependency
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Biotronik France
First posted: 2025-01-01
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have TAVR and who are considered to need permanent pacemaker implantation before hospital discharge relating to high degree, symptomatic or not, conductive disorders

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

Eligibility criteria: Inclusion Criteria:

all patients who need a permanent pacemaker implantation after TAVR

Exclusion Criteria:

Patients who have already a pace maker before TAVR

Primary outcomes:
measure: pacing dependency at 1 year follow-up
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
References: