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Intraindividual Ventricular Activation with Novel Combined Approach (LBBAP and LV-CS): IVANCA Study

Intraindividual Ventricular Activation with Novel Combined Approach (LBBAP and LV-CS): IVANCA Study - IVANCA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036981
Enrollment
12
Registered
2025-05-21
Start date
2025-04-02
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

I50.13

Interventions

Group 1: Arm 1 comprises cardiac resynchronization therapy (CRT) with combined stimulation of the left ventricle via left bundle branch area pacing (LBBAP) and coronary sinus stimulation (LV-CS), refe

Sponsors

Evangelisches Waldkrankenhaus Spandau
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: HFrEF, LVEF<35%, LBBB on ECG

Exclusion criteria

Exclusion criteria: Age <18 Known anatomical anomalies of CS or other anatomical obstacles for placing the LBBAP or CS lead.

Design outcomes

Primary

MeasureTime frame
Comparison of QRS width in 12-lead ECG between the three stimulation modes (LBBAP-only, LBBAP+LV-CS, LV-CS only) after four weeks per mode. The hypothesis is that the combined stimulation (LBBAP+LV-CS, Super-CRT) yields the narrowest QRS width

Secondary

MeasureTime frame
comparison of echocardiographic parameters (cardiac index, left ventricular ejection fraction (LVEF), strain) between the three stimulation modes (LBBAP-only, LBBAP+LV-CS, LV-CS only) after four weeks per mode. Comparison of NTproBNP levels between the stimulation modes after four weeks per mode. Comparison of subjective well-being using the VAS (Visual Analog Scale) between the stimulation modes after four weeks per mode. The hypothesis is that the combined stimulation (LBBAP+LV-CS, Super-CRT) yields the best results

Countries

Germany

Contacts

Public ContactDavit Saghabalyan

Evangelisches Waldkrankenhaus Spandau

davit.saghabalyan@jsd.de+493037022704

Outcome results

None listed

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