Hospital Universitari Germans Trias i Pujol, Department of Cardiology
Badalona, Barcelona, 08916, Spain
NCT Number: NCT07831655
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Badalona, Barcelona, 08916, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months after pacemaker implantation
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 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: Baseline to 6 months
is the direct arithmetic difference between two percentage measurements of blood pumped out of the heart's main chamber.
Time frame: 6 months
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
the total length a person can walk on a flat, hard surface during a period of six minutes
Time frame: Baseline and 6 months
N-terminal pro-B-type natriuretic peptide concentration in pg/mL
Time frame: Through study follow-up (6 months)
Any hospitalization due to heart failure decompensation
Time frame: Through study follow-up (6 months)
Mortality
Time frame: Through study follow-up (6 months)
Any problems with system pacing conduction
Time frame: Through study follow-up (6 months)
The protocol specified study interruption if this rate exceeded 10%.
Germans Trias i Pujol Hospital
Other
Conduction System Pacing to Preserve Left Ventricular Function in Patients Requiring Permanent Ventricular Pacing: The PRESERVE-CSP Randomized Trial
Acronym: PRESERVE-CSP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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