Left Bundle Branch Area Pacing versus Right Ventricular Pacing to Maintain Physiological Ventricular Activation in Patients with Normal or Mildly Reduced Left Ventricular Ejection Fraction

Left Bundle Branch Area Pacing versus Right Ventricular Pacing to Maintain Physiological Ventricular Activation in Patients with Normal or Mildly Reduced Left Ventricular Ejection Fraction - Preserve-Synch

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037542

Enrollment

200

Registered

2025-09-03

Start date

2025-09-04

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacing-induced cardiomyopathy

Interventions

Group 1: Conventional right ventricular pacing (RVP) Group 2: Left Bundle Branch Area Stimulation (LBBAP)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Key inclusion criteria: 1. Guideline Indication for ventricular pacing and an expected ventricular pacing burden >20%, due to (a) third-degree AV-block, (b) second degree AV-block, (c) first degree AV-block and PR interval > 320ms 2. Left ventricular ejection fraction (LVEF)= 40% at screening 3. Male or female, age =18 years 4. Written informed consent

Exclusion criteria

Exclusion criteria: Key exclusion criteria: 1. Planned coronary revascularization, transcatheter aortic valve implantation (TAVI), or MitraClip after randomization 2. Myocardial infarction, coronary revascularisation, TAVI, or MitraClip within 3 months before randomization 3. Severe systemic illness with a life expectancy < 3 years

Design outcomes

Primary

Measure	Time frame
Co-Primary Efficacy Endpoint: Decline of left ventricular global longitudinal strain (LV GLS) and increase in plasma levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP).The change from baseline within each treatment arm and the difference between treatment arms will be analyzed at 12 months. All patients will be followed-up in clinical visits until month 12 (follow-up visits at 3, 6 and 12 months). The recruitment period of 12 months leads to a total follow-up time of 24 months for the first included patient and 12 months for the last included patient.	—

Measure

Time frame

Co-Primary Efficacy Endpoint: Decline of left ventricular global longitudinal strain (LV GLS) and increase in plasma levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP).The change from baseline within each treatment arm and the difference between treatment arms will be analyzed at 12 months. All patients will be followed-up in clinical visits until month 12 (follow-up visits at 3, 6 and 12 months). The recruitment period of 12 months leads to a total follow-up time of 24 months for the first included patient and 12 months for the last included patient.

—

Secondary

Measure	Time frame
1. QRS width (for futility interims analysis) 2. Decrease of myocardial work 3. Development of pacemaker-induced cardiomyopathy (PICM), defined as =10% reduction in LVEF and a LVEF <50% 4. Hospitalization for heart failure 5. All-cause mortality 6. Upgrade to cardiac resynchronization (CRT) therapy 7. Change in NYHA functional class 8. Change in quality of life (SF-36 questionnaire) 9. Atrial fibrillation burden 10. Change in echocardiographic measures of LV function and morphology (cardiac dimensions, left atrial strain, right ventricular function, valve function)	—

Measure

Time frame

1. QRS width (for futility interims analysis) 2. Decrease of myocardial work 3. Development of pacemaker-induced cardiomyopathy (PICM), defined as =10% reduction in LVEF and a LVEF <50% 4. Hospitalization for heart failure 5. All-cause mortality 6. Upgrade to cardiac resynchronization (CRT) therapy 7. Change in NYHA functional class 8. Change in quality of life (SF-36 questionnaire) 9. Atrial fibrillation burden 10. Change in echocardiographic measures of LV function and morphology (cardiac dimensions, left atrial strain, right ventricular function, valve function)

—

Countries

Germany

Contacts

Public ContactFlorian Blaschke / PD Dr. Moritz Sinner

Charité, Universitätsmedizin Berlin und LMU Klinikum

florian.blaschke@dhzc-charite.de+49-30-450-653550

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026