An interventional study of conduction system pacing and right ventricular or biventricular pacing in Atrioventricular Block, Second and Third Degree, sponsored by Medical University of Silesia. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Medical University of Silesia · Not applicable, Interventional, and Prevention
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).
A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.
117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.
This study's planned enrollment of 500 is above the median of 127 across 78 interventional studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
Device: conduction system pacing
Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF \>= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines.
Device: right ventricular or biventricular pacing
Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.
Heart Failure Hospitalization
Hospitalization due to heart failure as a main reason
Time frame: 12 months
All-cause death
Death from any cause
Time frame: 12 months
Change in exercise capacity
Improvement or deterioration in exercise capacity assessed as a change of ≥1 New York Heart Association (NYHA) functional class or a change in 6-Minute Walk Test (6MWT) distance by 55m or more
Time frame: 24 months
Response to Cardiac Resynchronization Therapy (CRT)
Meeting the echocardiographic criteria of response to CRT defined as a decrease in Left Ventricular End Systolic Volume by ≥15% or an increase in Left Ventricular Ejection Fraction by ≥5% from the baseline values
Time frame: 24 months
Pacing-Induced Cardiomyopathy (PICM)
Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by \>=10% to the absolute value of \<50%
Time frame: 24 months
Change in global longitudinal strain (GLS)
An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%.
Time frame: 24 months
Atrial Fibrillation (AF) episodes
Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF).
Time frame: 24 months
Atrial High Rate Episodes (AHRE) in pacemaker recordings
Occurrence or change of the burden of AHRE events in the records from the CIED.
Time frame: 24 months
Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)
pl/mL
Time frame: 24 months
Change in Quality of Life
Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome.
Time frame: 24 months
Plan to share: No
Started Feb 2024 (actual). Primary completion is estimated for May 2028, 51 months after the start.
Of 44 interventional studies with no phase under Atrioventricular Block, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 51 months is above that.
How these figures are worked out, and which studies are left out of them.
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