Using physiological pacing to prevent heart issues from pacemakers
Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
This study is testing if a new way of pacing the heart can help people with slow heartbeats and blockages avoid heart problems caused by traditional pacemakers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05214365 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of conduction system pacing as an alternative to conventional ventricular pacing in patients with atrioventricular block and bradycardia. The goal is to prevent pacemaker-induced cardiomyopathy (PICM), a condition that can arise from traditional pacing methods. Participants will undergo pacemaker implantation and will be monitored through clinical, electrocardiographic, and echocardiographic assessments over the course of one year. The study aims to demonstrate that physiological pacing can improve heart function by ensuring proper electrical activation of the heart.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with preserved ejection fraction and a clinical indication for pacemaker implantation due to atrioventricular block.
Not a fit: Patients with severe comorbidities, cognitive impairments, or those unable to attend follow-up visits may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of heart function deterioration in patients requiring pacemakers.
How similar studies have performed: While the approach of conduction system pacing is gaining interest, its effectiveness compared to conventional pacing is still being evaluated, making this study a significant contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient must be ≥ 18 years of age. * The patient must indicate their acceptance to participate in the study by signing an informed consent document. * Patients with EF\> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines. Exclusion Criteria: * Inability to understand and sign the informed consent. * Patients with severe comorbidities and life expectancy \<1 year. * Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life. * Patients who cannot come to our center to carry out the follow-up of the study.
Where this trial is running
Barcelona
- Hospital Clinic of Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Jose M Tolosana, MD, PhD — Hospital Clinic of Barcelona
- Study coordinator: Lluís Mont, MD, PhD
- Email: lmont@clinic.cat
- Phone: +34 93 2271778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.