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One Year Pacing Dependency After TAVR

Pacing Dependence at 1 Year Follow-up in Patients Implanted With a Pacemaker After TAVR: a Multicenter Observational Study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06756282
Acronym
PACETAVI
Enrollment
90
Registered
2025-01-01
Start date
2024-11-13
Completion date
2027-10-13
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis (Treated With TAVI), Pacing Therapy, Patient Discharge, Patients Above 18 Years

Keywords

transcatheter aortic valve replacement (TAVR), permanent pacing, conductive disorders, pacing dependency

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

Interventions

only patients with pacemaker implantation will be evaluated in the study

Sponsors

Biotronik France
CollaboratorINDUSTRY
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

all patients who need a permanent pacemaker implantation after TAVR

Exclusion criteria

Patients who have already a pace maker before TAVR

Design outcomes

Primary

MeasureTime frameDescription
pacing dependency at 1 year follow-up6 monthspacing 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

Countries

France

Contacts

Primary ContactFlorence Leclercq, PUPH
f-leclercq@chu-montpellier.fr0467336189

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026