MASTER-LV2

Permanent left bundle branch–optimized cardiac resynchronization therapy in patients with heart failure with reduced ejection fraction and prolonged QRS duration: the MASTER-LV2 study - MASTER-LV2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58277

Enrollment

Registered

2025-05-09

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Dyssynchronous heart failure, heart failure with reduced ejection fraction Heart failure with reduced pump function

Interventions

Pacemaker or ICD implantation with a left ventricular and left bundle branch area pacing lead (LOT-CRT).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Class I or II CRT-indication (CRT-P or CRT-D):- Chronic heart failure with NYHA functional class II-IV- SR at implantation- Left ventricular ejection fraction (LVEF) = 35%- QRS duration = 130 ms- Optimal medical heart failure therapy

Exclusion criteria

Exclusion criteria: - CIED upgrade implantations will be excluded; only first implantations are allowed- Age < 18 years- Permanent AF- Patients on hemodialysis- Active infection- Myocardial infarction < 3 months before inclusion- Hypertrophic cardiomyopathy- Cardiac Sarcoidosis- Cardiac Amyloidosis- Life expectancy < 1 year- Incapable of giving informed consent

Design outcomes

Primary

Measure	Time frame
The primary outcome measures of the MASTER-LV 2 study are:1. Differences in VEH between the different pacing modalities as assessed by:- Electrocardiography: QRS duration.- Vectorcardiography: QRS area. - Ultra high frequency ECG: Edys, LV dys, Vdmean.  2. Differences in haemodynamics between the different pacing modalities as assessed by:- Invasively measured blood pressure.These parameters will be measured during the different pacing protocols during implantation.	—

Measure

Time frame

The primary outcome measures of the MASTER-LV 2 study are:1. Differences in VEH between the different pacing modalities as assessed by:- Electrocardiography: QRS duration.- Vectorcardiography: QRS area. - Ultra high frequency ECG: Edys, LV dys, Vdmean.  2. Differences in haemodynamics between the different pacing modalities as assessed by:- Invasively measured blood pressure.These parameters will be measured during the different pacing protocols during implantation.

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Secondary

Measure	Time frame
Secondary endpoints are:- implant success rate;- improvement of LV function, dimensions and strain measured by echocardiography at six months follow-up compared to baseline before implantation, and- the efficacy of real-time image (CT)-guided LBBAP and LV-CS lead delivery to a pre-defined target in a subgroup of 15 patients.- comparison of photon counting cardiac CT and cardiac MRI scan derived cardiac fibrosis and extracellular volume	—

Measure

Time frame

Secondary endpoints are:- implant success rate;- improvement of LV function, dimensions and strain measured by echocardiography at six months follow-up compared to baseline before implantation, and- the efficacy of real-time image (CT)-guided LBBAP and LV-CS lead delivery to a pre-defined target in a subgroup of 15 patients.- comparison of photon counting cardiac CT and cardiac MRI scan derived cardiac fibrosis and extracellular volume

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Countries

Netherlands

Contacts

Public ContactJ.G.L.M. Luermans

Maastricht Universitair Medisch Centrum +

justin.luermans@mumc.nl0433876543

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026