Actively Recruiting
Physiological Pacing vs Conventional Pacing in Preventing Pacemaker-induced Cardiomyopathy: A Randomized Study
Led by Hospital Clinic of Barcelona · Updated on 2026-03-31
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospital Clinic of Barcelona
Lead Sponsor
I
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates two methods of pacemaker implantation for patients with atrioventricular block and slow heart rate (bradycardia). The study compares conventional right ventricular pacing, which can sometimes reduce heart function causing pacemaker-induced cardiomyopathy (PICM), with conduction system pacing that aims to preserve natural heart activation and potentially prevent PICM. The research follows patients clinically and with heart imaging for one year to evaluate outcomes. Participants will receive either a traditional pacemaker with the lead placed in the apex or septal area of the right ventricle, or pacing targeting the his bundle or left bundle branch to stimulate the heart's natural conduction system. The choice of electrode location and pacing method is randomized. Implantation parameters like sensing and pacing thresholds will be measured. Follow-up lasts one year after implantation. During the study, patients will undergo clinical exams, electrocardiograms, and echocardiograms to monitor heart function and pacing effects. Researchers will assess the incidence of pacemaker-induced heart disease over 12 months along with changes in heart volume, atrial fibrillation onset, heart failure hospitalizations, exercise capacity, quality of life, and safety events. The trial includes regular evaluations to compare the benefits and risks of both pacing techniques.
CONDITIONS
Brief Title
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older
- Patient agrees to participate by signing informed consent
- Patients with ejection fraction greater than 50%
- Patients have indication for pacemaker implantation due to atrioventricular block according to current guidelines
You will not qualify if you...
- Inability to understand or sign informed consent
- Severe comorbidities with life expectancy less than 1 year
- Severe cognitive impairment or dependence for basic daily activities
- Unable to attend follow-up visits at the study center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo pacemaker implantation with either conventional pacing or physiological conduction system pacing as assigned.
1 visit (in-person)
Duration - 12 months
Participants are monitored with clinical, electrocardiographic, and echocardiographic assessments to evaluate heart function and pacing parameters.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Actively Recruiting
Research Team
L
Lluís Mont, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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