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Completed

NCT Number: NCT07831655

Conduction System Pacing to Prevent Pacing-Induced Cardiomyopathy

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Germans Trias i Pujol, Department of Cardiology

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Left ventricular ejection fraction greater than 50% by the Simpson four-chamber method before pacemaker implantation.
  • Indication for permanent pacemaker implantation due to atrioventricular block.
  • Anticipated ventricular pacing burden greater than 85%.
  • At least one of the following high-risk features: structural heart disease or native QRS duration greater than 120 ms.
  • Structural heart disease was defined as previously diagnosed ischemic heart disease, with or without prior myocardial infarction, and/or at least moderate left-sided valvular stenosis or regurgitation, and/or an aortic or mitral valve prosthesis.
  • Provision of written informed consent.

Exclusion criteria

  • Failure to meet all inclusion criteria.
  • Refusal or inability to provide written informed consent.
  • Dementia or significant cognitive impairment.
  • Underlying systemic disease associated with a life expectancy of less than 1 year.

Treatment and study plan

Conduction system pacing

Procedure

The ventricular lead was implanted at the His bundle or at the left bundle branch region.

Right Ventricular Apical Pacing

Procedure

The ventricular pacing lead was implanted in the right ventricular apical region using conventional technique.

Primary outcomes

  1. Left ventricular ejection fraction at 6 months

    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.

  2. Pacing-induced cardiomyopathy at 6 months

    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.

Secondary outcomes

  1. Absolute change in left ventricular ejection fraction, in percentage points

    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.

  2. Minnesota Living with Heart Failure Questionnaire score

    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

  3. Six-minute walk distance (meters)

    Time frame: 6 months

    the total length a person can walk on a flat, hard surface during a period of six minutes

  4. NT-proBNP concentration

    Time frame: Baseline and 6 months

    N-terminal pro-B-type natriuretic peptide concentration in pg/mL

  5. Heart failure hospitalization

    Time frame: Through study follow-up (6 months)

    Any hospitalization due to heart failure decompensation

  6. All-cause and cardiac mortality

    Time frame: Through study follow-up (6 months)

    Mortality

  7. Failure of conduction system pacing (Safety)

    Time frame: Through study follow-up (6 months)

    Any problems with system pacing conduction

  8. Failure due to ventricular lead dislodgement or an increase in pacing threshold above 2.5 V at 1 ms.

    Time frame: Through study follow-up (6 months)

    The protocol specified study interruption if this rate exceeded 10%.

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

Conduction System Pacing to Preserve Left Ventricular Function in Patients Requiring Permanent Ventricular Pacing: The PRESERVE-CSP Randomized Trial

Acronym: PRESERVE-CSP

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

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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