NCT05868616

Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis. Cardiac resynchronization therapy (CRT) has been one of the most important advancements in the past two decades for patients with LBBB heart failure. However, 30-40% of patients receiving a CRT do not benefit from it. In this study, the investigators will test a noninvasive device to evaluate acute effect of CRT during implantation and at follow-up CRT controls. In addition, echocardiography will be performed during CRT turned ON and OFF to visualize the changes in intraventricular flow and functional parameters of the heart.

Conditions

• Heart Failure
• Pacemaker DDD
• Cardiomyopathies
• Heart Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Cardiac Resynchronization Therapy (CRT)	Cardiac resynchronization therapy (CRT) is a modality of cardiac pacing used in patients with left ventricular (LV) systolic dysfunction and dyssynchronous ventricular activation that provides simultaneous or nearly simultaneous electrical activation of the LV and right ventricle (RV) via stimulation of the LV and RV (biventricular pacing) or LV alone.

Timeline

• Start date: 2023-03-21
• Primary completion: 2027-03-01
• Completion: 2031-03-01
• First posted: 2023-05-22
• Last updated: 2025-08-06

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated device study