One Year Pacing Dependency After TAVR

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Montpellier

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pacemaker and defibrillator

    Procedure/Surgery

    only patients with pacemaker implantation will be evaluated in the study

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Patients who need permanent pace maker implantation after TAVR1 intervention

Trial outcomes

Primary outcomes

1

pacing dependency at 1 year follow-up

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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