Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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:

‣ Sinus rhythm.

⁃ New York Heart Association class II / III heart failure on diagnosis and on optimal medical therapy.

⁃ Left bundle branch block.

⁃ QRS duration ≥ 130 ms.

⁃ Left ventricular ejection fraction ≤ 40%.

⁃ Patients must have echocardiography examination before implantation

⁃ Informed consent obtained from the patient.

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Espen W. Remme, Dr.ing
espen.remme@medisin.uio.no
004723071413
Backup
Marit Witsø, MD
mhwitso@medisin.uio.no
004723071402
Time Frame
Start Date: 2023-03-21
Estimated Completion Date: 2031-03
Participants
Target number of participants: 80
Treatments
Group 1 - Implantation
Patients admitted for CRT implantation according to current ESC/AHA guidelines
Group 2 - 6 months control
Patients admitted for 6 months routine checkups of their CRT devices
Sponsors
Collaborators: Norwegian Health Association, South-Eastern Norway Regional Health Authority
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov