An interventional study of Conduction System Pacing and Right Ventricular Apical Pacing in Atrioventricular Block, Pacing-Induced Cardiomyopathy and Cardiac Pacing, Artificial, sponsored by Germans Trias i Pujol Hospital. Completed at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Germans Trias i Pujol Hospital · Not applicable, Interventional, and Prevention
The purpose of this randomized, open-label trial was to determine whether permanent conduction system pacing preserves left ventricular function and reduces the incidence of pacing-induced cardiomyopathy compared with conventional right ventricular apical pacing in patients with preserved LVEF who required permanent ventricular pacing for atrioventricular block and were considered at increased risk because of structural heart disease and/or a wide native QRS complex.
Eligible participants had an LVEF above 50%, an indication for permanent pacemaker implantation due to atrioventricular block, an anticipated ventricular pacing burden above 85%, and either underlying structural heart disease or a native QRS duration above 120 ms. After written informed consent, participants were randomized to conduction system pacing or right ventricular apical pacing. Clinical, electrocardiographic, echocardiographic, functional, quality-of-life, and biomarker assessments were performed at baseline and at 6 months as specified in the protocol. Subsequent routine pacemaker-clinic follow-up was used to ascertain clinical events.
117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.
This study's enrollment of 116 is close to the median of 127 across 78 interventional studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →Germans Trias i Pujol Hospital is the lead sponsor of 89 studies on the registry; 12 are open to participants now.
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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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Conduction System Pacing
Procedure: Right Ventricular Apical Pacing
The ventricular lead was implanted at the His bundle or at the left bundle branch region.
The ventricular pacing lead was implanted in the right ventricular apical region using conventional technique.
Left ventricular ejection fraction at 6 months
Left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography using the Simpson method and expressed as a percentage, compared between the conduction system pacing and right ventricular apical pacing groups.
Time frame: 6 months after pacemaker implantation
Pacing-induced cardiomyopathy at 6 months
Pacing-induced cardiomyopathy was defined as an absolute decrease in LVEF of more than 10 percentage points from baseline resulting in an LVEF below 50%, in the absence of an alternative cause, compared between study groups.
Time frame: 6 months after pacemaker implantation
Absolute change in left ventricular ejection fraction, in percentage points
is the direct arithmetic difference between two percentage measurements of blood pumped out of the heart's main chamber.
Time frame: Baseline to 6 months
Minnesota Living with Heart Failure Questionnaire score
ranges from 0 to 105, where a lower score indicates a better quality of life and a higher score represents a worse quality of life
Time frame: 6 months
Six-minute walk distance (meters)
the total length a person can walk on a flat, hard surface during a period of six minutes
Time frame: 6 months
NT-proBNP concentration
N-terminal pro-B-type natriuretic peptide concentration in pg/mL
Time frame: Baseline and 6 months
Heart failure hospitalization
Any hospitalization due to heart failure decompensation
Time frame: Through study follow-up (6 months)
All-cause and cardiac mortality
Mortality
Time frame: Through study follow-up (6 months)
Failure of conduction system pacing (Safety)
Any problems with system pacing conduction
Time frame: Through study follow-up (6 months)
Failure due to ventricular lead dislodgement or an increase in pacing threshold above 2.5 V at 1 ms.
The protocol specified study interruption if this rate exceeded 10%.
Time frame: Through study follow-up (6 months)
Plan to share: No — Individual participant data will not be shared with third parties, in accordance with the study's data protection and privacy policies and applicable data protection regulations.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Germans Trias i Pujol Hospital