A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone (LOT or NOT)
Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy and may offer advantages over conventional biventricular pacing (BVP), including improved clinical outcomes. However, its effectiveness may be limited in patients with distal conduction system disease, significant endocardial and/or myocardial damage, as well as when direct left bundle branch capture is not achieved. Conventional CRT remains an effective therapy but is associated with procedural challenges and a significant non-responder rate. Current guidelines support the use of LBBAP and BVP either individually or in combination as Left Bundle Branch Optimized CRT (LOT-CRT). Recent data suggest that LOT-CRT may provide superior electrical and hemodynamic resynchronization compared with both LBBAP and BVP. However, there is a lack of randomized trials comparing LBBAP and LOT-CRT in patients with CRT-P indication. The aim of this study is to compare the LOT-CRTP to LBBAP alone.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Guram PD Dr. Imnadze
- Telefonnummer: +491733728489
- E-Mail: g.imnadze@ukrb.de
Studienorte
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Brandenburg
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Neuruppin, Brandenburg, Deutschland, 16816
- University Hospital Ruppin-Brandenburg
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Kontakt:
- Guram Imnadze, MD, PhD
- Telefonnummer: +493391393111
- E-Mail: imnadze@web.de
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Age ≥ 18 years Clinical indication for CRTP implantation according to the current ESC guidelines De novo implantation LBBB (QRS duration ≥130 ms) NYHA II-IV
Exclusion Criteria:
Severe mitral or aortic valvular disease History of VT/VF Failed implantation of any component of the LOT-CRTP system/ incompleteness of the system to be implanted Pregnancy Life expectancy < 1 year Inability to give written consent
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Sonstiges: LOT group
LOT group: Implanted with LOT-CRT-P device and programmed with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG. |
Device: LOT-CRT-P (Programming: LOT-CRT-P) All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead. Device programming: LOT group: Pacing with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG. After 12 months and study end, each patient receives a personalised and optimally tailored adjustment. |
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Sonstiges: NOT group (LBBAP)
NOT group: Implanted with LOT-CRT-P device and programmed with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms. |
All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead. Device programming: NOT group: Synchronized with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms. After 12 months and study end, each patient receives a personalised and optimally tailored adjustment. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Clinical Status
Zeitfenster: From enrollment to 12 month follow up
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Hierarchical clinical composite score: 1. Patients who died for a cardiovascular cause, received a heart transplantation or had an unplanned emergency department visit or hospitalization for heart failure are 'unchanged/worsened'. 2. Patients who receive a modification of the implanted CRTP system for reasons of presumed inefficacy of the randomized system are 'unchanged/worsened'. 3. Patients to whom the above does not apply and who have >20% absolute increase in LVEF at 12 months or earlier are 'markedly improved', and patients who have <5% absolute increase in LVEF at 12 months are 'unchanged/worsened' 4. Patients to whom the above does not apply the KCCQ-12 overall summary score will be assessed. Those who have ≥ 5 points increase in KCCQ-12 overall summary score are 'markedly improved', and patients who have ≥5 points decrease are 'unchanged/worsened'. 5. Patients for whom none of the conditions above apply, are 'moderately improved'. |
From enrollment to 12 month follow up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Electrocardiographic characteristics
Zeitfenster: enrollment to 12 month follow up
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ECG: QRS duration, assessment of LV lateral wall activation time and LV lateral wall to RV septal activation time. |
enrollment to 12 month follow up
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Echocardiographic characteristics
Zeitfenster: enrollment to 12 month follow up
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left ventricular ejection fraction (LVEF), left ventricular end-systolic/ end-diastolic volume (LVESV/LVEDV), LV EDD, LV ESD. |
enrollment to 12 month follow up
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NYHA class
Zeitfenster: enrollment to 12 month follow up
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enrollment to 12 month follow up
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NT-ProBNP
Zeitfenster: enrollment to 12 month follow up
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enrollment to 12 month follow up
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6 minutes walking test
Zeitfenster: enrollment to 12 month follow up
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enrollment to 12 month follow up
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Quality of Life Questionaire
Zeitfenster: enrollment to 12 month follow up
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KCCQ-12 |
enrollment to 12 month follow up
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Worsened heart failure
Zeitfenster: enrollment to 12 month follow up
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enrollment to 12 month follow up
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Arrhythmic events
Zeitfenster: enrollment to 12 month follow up
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VT/VF/AF occurrence |
enrollment to 12 month follow up
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Mortality
Zeitfenster: enrollment to 12 month follow up
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enrollment to 12 month follow up
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
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
- FF109
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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