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Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conduction (MORE-CSP)

13. maj 2026 opdateret af: Óscar Cano Pérez

Intraventricular conduction delay alone or in combination with AV conduction delay is associated with a dyssynchronous activation of the ventricles and may result in LV function impairment.

Conduction system pacing can restore physiologic ventricular activation in the presence of intraventricular and atrioventricular conduction delays.

Patients with intraventricular conduction delay alone or in combination with AV conduction delay who have a permanent pacemaker indication due to intermittent bradycardia and have predominantly intact AV conduction may benefit from continuous CSP.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study design: Multicenter, prospective, randomized, cross-over, patient-blinded study

Study Objectives:

  • Primary objective: The primary objective of the study is to demonstrate that CSP is associated with better LVEF and GLS preservation at 12-month follow-up in comparison to native conduction with wide QRS. The percentages of patients with a ≥10% decline in LVEF and or ≥ 15% decline in GLS between groups will be considered for the primary outcome.
  • Principal secondary objectives: NYHA class at 12 months, Walking distance in 6 minutes walking test, Quality of life (EQ EQ 5D), To evaluate reverse ventricular remodeling response and dyssynchrony parameters based on echocardiographic data at 12 months follow-up, To evaluate device battery longevity estimation at 12-month follow-up, To evaluate HF related hospitalizations/ER visits at 12 months follow-up, To evaluate mortality (global and cardiovascular) at 12-month follow-up, To evaluate incidence of ventricular arrhythmias at 12-month follow-up, To evaluate differences in LVEF and remodeling parameters depending on the final CSP modality (LBBP vs LVSP), To evaluate device related complications at 12-month follow-up, To evaluate differences between pacing indication groups (acute LBBB vs unknown/chronic wide QRS)and To evaluate percentage of patients randomized to continuous pacing who loose AV conduction after 12 months of continuous pacing Primary Endpoint: LVEF decrease ≥ 10% and/or GLS decrease ≥ 15% at 12-month follow-up with respect to baseline value

Study population criteria

  • Inclusion criteria: age > 18 years, Any indication for cardiac pacing with an expected VP burden ≤ 10% after 1-month run-in period, Baseline wide QRS (≥150 ms) with normal PR or QRS ≥ 130 ms + PR≥230 ms, Confirmed CSP criteria (LBBAP including LBBP and LVSP), LVEF≥50% and Signed and dated informed consent.
  • Exclusion criteria: Pregnant woman, Age < 18 years, Permanent or long-lasting atrial fibrillation, Previous PM/ICD, Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), valve repair or replacement within 90 days prior enrollment, Moderate-severe valvular heart disease (not repaired), Already included in another clinical study that could confound the results of the present study, Infiltrative disease or any other genetically or acquired primary myocardial disease, Life expectancy < 2 years and LVEF <50%

Sample size: 120 patients will be enrolled in the study.

Devices: Only CE-marked pacemaker devices locally approved and commercially available shall be used in this protocol.

Statistical considerations: Once patients have signed the informed consent at baseline visit, patients will be considered as "Enrolled population" in the statistical analysis.

The sample size is based on the primary endpoint: LVEF decrease ≥ 10% and/or ≥ 15% decrease in GLS at 12-month follow- up with respect to baseline value.

Accounting for an attrition rate of 15% due to lost to follow-up or cross-over and considering the block size for randomization, 120 patients shall be enrolled

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Óscar Cano, MD, PhD
  • Telefonnummer: 440079 +34 961244000
  • E-mail: cano_osc@gva.es

Undersøgelse Kontakt Backup

  • Navn: Bernabé López, MD
  • Telefonnummer: 412713 +34 961244000

Studiesteder

  • Spanien
    • Andalusia
      • Granada, Andalusia, Spanien, 18014
        • Rekruttering
        • Hospital Universitario Virgen de Las Nieves
        • Kontakt:
    • Aragon
      • Zaragoza, Aragon, Spanien, 50009
        • Rekruttering
        • Hospital Clínico Universitario Lozano Blesa
        • Kontakt:
    • Valencia
      • Valencia, Valencia, Spanien, 46026
        • Rekruttering
        • Hospital Universitari i Politecnic La Fe
        • Kontakt:
          • Óscar Cano, MD, PhD
          • Telefonnummer: 440079 +34 961244000
          • E-mail: cano_osc@gva.es

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • age > 18 years
  • Any indication for cardiac pacing with an expected VP burden ≤ 10% after 1- month run-in period
  • Baseline wide QRS (≥150 ms) with normal PR or QRS ≥ 130 ms + PR≥230 ms
  • LVEF≥50%
  • Confirmed CSP criteria
  • Signed and dated informed consent

Exclusion Criteria:

  • Pregnant woman
  • Permanent or long-lasting atrial fibrillation
  • Previous PM/ICD
  • Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), surgical valve repair or replacement within 90 days prior enrollment
  • Moderate-severe valvular heart disease (unrepaired)
  • Already included in another clinical study that could confound the results of the present study
  • Infiltrative disease or any other genetically or acquired primary myocardial disease
  • Life expectancy < 2 years
  • LVEF <50%

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: CSP ON
Continuous Conduction System Pacing (CSP)
Enhed: Pacemaker implant

All patients will receive a ventricular lead in the conduction system (HBP or LBBAP) using conventional implant techniques described elsewhere. The pacemaker device and leads should be implanted according to the physician's manual provided with the devices. Only locally approved Medtronic PM generators with MVP algorithms will be used during the study.

Investigators will use the Medtronic Select Secure 3830 lead for CSP. Acceptable LBBAP threshold should be <2,5V@0,5ms. Other commercially available stylet driven leads may be used as bail-out strategy only when CSP cannot be achieved with the 3830 lead at the implanting physician discretion.

During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA).

It is strongly encouraged the designation of a single and experienced CSP implanting physician at each center.
Placebo komparator: CSP OFF
Non active Conduction System Pacing (CSP)
Enhed: Pacemaker implant

All patients will receive a ventricular lead in the conduction system (HBP or LBBAP) using conventional implant techniques described elsewhere. The pacemaker device and leads should be implanted according to the physician's manual provided with the devices. Only locally approved Medtronic PM generators with MVP algorithms will be used during the study.

Investigators will use the Medtronic Select Secure 3830 lead for CSP. Acceptable LBBAP threshold should be <2,5V@0,5ms. Other commercially available stylet driven leads may be used as bail-out strategy only when CSP cannot be achieved with the 3830 lead at the implanting physician discretion.

During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA).

It is strongly encouraged the designation of a single and experienced CSP implanting physician at each center.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation
Tidsramme: 12 months
Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Óscar Cano Pérez

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. juli 2025

Primær færdiggørelse (Anslået)

15. januar 2028

Studieafslutning (Anslået)

15. januar 2029

Datoer for studieregistrering

Først indsendt

15. juli 2025

Først indsendt, der opfyldte QC-kriterier

10. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MORE-CSP

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Bradykardi

  • SABAMED Medical Center Ltd.
    Rekruttering
    Polsk registreringsdatabase af cardioneuroablation og cardioneuromodulation (POL-CA)
    Ortostatisk hypotension | Mikrovaskulær angina | Ventrikulær arytmi | Vasospastisk angina | Autonom dysfunktion | Raynauds fænomener | Autonome sygdomme | Vasovagal syndrom VVS | Cardioinhibitory carotis sinus syndrom CSS | Symptomatisk sinus Bradycardia SB eller atrioventrikulær blok AV | Postural Orthostatic... og andre forhold
    Polen

Kliniske forsøg med Pacemaker implant

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