An interventional study of Pacemaker implant in Complete Heart Block and Second Degree Atrioventricular Block Möbitz Type II, sponsored by Institut d'Investigació Biomèdica de Bellvitge. Recruiting at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by Institut d'Investigació Biomèdica de Bellvitge · Not applicable, Interventional, and Prevention
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction >50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.
Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.
117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.
This study's planned enrollment of 326 is above the median of 127 across 78 interventional studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →Institut d'Investigació Biomèdica de Bellvitge is the lead sponsor of 19 studies on the registry; 9 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.
The ventricular lead will be penetrated into the basal interventricular septum aiming at left septal pacing and, if not possible, at least deep septal pacing with a paced QRS duration \<=140ms.
Device: Pacemaker implant
The ventricular lead will be placed in the right ventricular apex.
Device: Pacemaker implant
All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead.
Pacing-induced cardiomyopathy
Decrease in the left ventricular ejection fraction (LVEF) by \>10% as compared to the LVEF before pacemaker implant and final LVEF\<45%.
Time frame: 12 months
LVEF during follow-up
To compare the mean or median (depending on distribution) LVEF before and one year after pacemaker implant in the two groups.
Time frame: 12 months
Mitral and tricuspid regurgitation
To compare the degree of mitral and tricuspid regurgitation before and one year after pacemaker implant in the two groups.
Time frame: 12 months
New York Heart Association (NYHA) class
To compare the NYHA class one year after pacemaker implant in the two groups.
Time frame: 12 months
Brain Natriuretic Peptide levels
To compare the N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels one year after pacemaker implant in the two groups.
Time frame: 12 months
heart failure
Comparison of heart failure (HF) events in the first year after pacemaker implant in the two groups. HF events will be: hospitalizations for heart failure, emergency department or day-hospital visits for heart failure, heart failure symptoms requiring the initiation of diuretic therapy.
Time frame: 12 months
Complications
Complications related to the ventricular lead
Time frame: 12 months
Plan to share: Yes — The study protocol and the informed consent form will be available upon request during the whole duration of the study.
Supporting information: Study protocol, Informed consent form
Time frame: During the whole duration of the study
Access criteria: Request to the principal investigator.
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Institut d'Investigació Biomèdica de Bellvitge