Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pacemaker implant.
- Who it may be relevant to
- Registry conditions: Complete Heart Block, Second Degree Atrioventricular Block Möbitz Type II. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Pacemaker implant
All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead.
Primary outcome measures
- Pacing-induced cardiomyopathy [Time frame: 12 months]
Secondary outcome measures (5)
- LVEF during follow-up [Time frame: 12 months]
- Mitral and tricuspid regurgitation [Time frame: 12 months]
- New York Heart Association (NYHA) class [Time frame: 12 months]
- Brain Natriuretic Peptide levels [Time frame: 12 months]
- heart failure [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Spain · 6 centers
- Hospital Vall d'Hebrón — Barcelona
- Hospital General Universitario de Castellón — Castellon
- Hospital Virgen de las Nieves — Granada
- Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat
- Hospital La Fe — Valencia
- Hospital Lozano Blesa — Zaragoza
Identifiers
NCT: NCT06474819 · DEEP