Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Bellvitge
About this trial
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.
Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.
Eligibility criteria
Qualifiers
First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (<45lpm).
LVEF>50% at echocardiography performed maximum 7 days before pacemaker implant.
Informed consent signature.
Disqualifiers
Life expectancy <12 months
Severe cardiac valvular abnormality requiring intervention
Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.
Inclusion in another trial which may influence the results of this study.
Trial design
Treatments tested in this trial
- Pacemaker implant
Treatment groups
326 Participants
are divided into 2 treatment groupsSponsors and collaborators
Institut d'Investigació Biomèdica de Bellvitge
Lead sponsor
Fundació La Marató de TV3
Collaborator
Hospital Universitari de Bellvitge
Collaborator
Source ClinicalTrials.gov