Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Compare the incidence of pacemaker-induced heart disease
Study Overview
Brief Summary
The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.
Detailed Description
Pacemaker implantation and conventional cardiac stimulation from the right ventricle is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. But it can cause worsening of heart function, with a significant drop in LV ejection fraction, known as pacemaker-induced cardiomyopathy (PICM).
Conduction system pacing (either by his or left bundle branch pacing) causes a physiological left ventricular activation through the normal conduction system thus correcting the electrical and mechanical asynchrony caused by conventional pacing. Conduction system pacing may prevent the appareance of PICM.
Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The patient will be explained to be randomized to either one of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Compare the incidence of pacemaker-induced heart disease
Time Frame: 12 months
Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF \<45% or admission due to heart failure.
Secondary Outcomes
- Correction of septal flash.(12 Months)
- Total implantation and electrode implantation times.(12 Months)
- Change in end-systolic volume.(12 Months)
- The Quality of Life Scale.(12 Months)
- NT-proBNP.(12 Months)
- Incidence of new onset of atrial fibrillation.(12 Months)
- Adverse events.(12 Months)
- Hospitalization due to heart failure.(12 Months)
- New York Heart Association functional classification.(12 Months)
- Pacing thresholds.(12 Months)
- Six minute walking test.(12 Months)
Investigators
Josep Lluis Mont Girbau
Head of Arrhythmia Section. Professor of Cardiology
Hospital Clinic of Barcelona