Actively Recruiting
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Led by Institut d'Investigació Biomèdica de Bellvitge · Updated on 2024-07-15
326
Participants Needed
6
Research Sites
130 weeks
Total Duration
On this page
Sponsors
I
Institut d'Investigació Biomèdica de Bellvitge
Lead Sponsor
F
Fundació La Marató de TV3
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia with high-degree atrioventricular block or atrial fibrillation with symptomatic slow ventricular rate (<45 bpm)
- Left ventricular ejection fraction greater than 50% on echocardiography performed within 7 days before pacemaker implant
- Signed informed consent
You will not qualify if you...
- Life expectancy less than 12 months
- Severe cardiac valvular abnormality requiring intervention
- Unstable angina, acute myocardial infarction, coronary revascularization, valvular surgery, or valvular percutaneous intervention within 90 days before pacemaker implant
- Participation in another trial that may affect this study's results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hospital Vall d'Hebrón
Barcelona, Spain
Not Yet Recruiting
2
Hospital General Universitario de Castellón
Castellon, Spain
Not Yet Recruiting
3
Hospital Virgen de las Nieves
Granada, Spain
Not Yet Recruiting
4
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Spain
Actively Recruiting
5
Hospital La Fe
Valencia, Spain
Not Yet Recruiting
6
Hospital Lozano Blesa
Zaragoza, Spain
Not Yet Recruiting
Research Team
A
Andrea Di Marco, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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