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Clinical Trials in Norway / NCT05868616
Recruiting Observational

Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

NCT05868616 · tracked via the Priya Life Science Norway tracker
Sponsor
Oslo University Hospital
Phase
Observational
Started
2023-03-21
Last updated
2025-08-06

Condition(s) studied

Heart FailurePacemaker DDDCardiomyopathiesHeart DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Cardiac Resynchronization Therapy (CRT)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients referred for CRT implantation or postoperative control at Oslo University Hospital based on the European Society of Cardiology (ESC) guidelines (2021), and criteria below: 1. Sinus rhythm. 2. New York Heart Association class II / III heart failure on diagnosis and on optimal medical therapy. 3. Left bundle branch block. 4. QRS duration ≥ 130 ms. 5. Left ventricular ejection fraction ≤ 40%. 6. Patients must have echocardiography examination before implantation 7. Informed consent obtained from the patient. Exclusion Criteria: 1. Age \< 18 years and \> 80 years; 2. Ongoing atrial fibrillation; 3. Complete atrioventricular block

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Oslo University Hospital Oslo Norway Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05868616 on ClinicalTrials.gov ↗ ← All trials in Norway