Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

NCT05868616 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-08-06

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER
  • Norwegian Health Association

    collaborator OTHER
  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Espen W. Remme, Dr.ing · Oslo University Hospital

  • Marit Witso, MD · Oslo University Hospital

  • Hongxing Luo, MD, PhD · Oslo University Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2027-03-31
Completion
2031-03-31
FDA Device
Yes

Countries

  • Norway

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868616 on ClinicalTrials.gov