Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conduction (MORE-CSP)
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.
Studienübersicht
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Óscar Cano, MD, PhD
- Telefonnummer: 440079 +34 961244000
- E-Mail: cano_osc@gva.es
Studieren Sie die Kontaktsicherung
- Name: Bernabé López, MD
- Telefonnummer: 412713 +34 961244000
Studienorte
-
-
Andalusia
-
Granada, Andalusia, Spanien, 18014
- Rekrutierung
- Hospital Universitario Virgen de las Nieves
-
Kontakt:
- Manuel Molina, MD
- Telefonnummer: +34 958020000
- E-Mail: manuel.molina.lerma@gmail.com
-
-
Aragon
-
Zaragoza, Aragon, Spanien, 50009
- Rekrutierung
- Hospital Clínico Universitario Lozano Blesa
-
Kontakt:
- Javier Ramos, MD
- Telefonnummer: +34 976765700
- E-Mail: javierramosmaqueda7@gmail.com
-
-
Valencia
-
Valencia, Valencia, Spanien, 46026
- Rekrutierung
- Hospital Universitari i Politecnic La Fe
-
Kontakt:
- Óscar Cano, MD, PhD
- Telefonnummer: 440079 +34 961244000
- E-Mail: cano_osc@gva.es
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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%
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: CSP ON
Continuous Conduction System Pacing (CSP)
|
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)
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MORE-CSP
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .