Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

NCT ID: NCT05868616

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2031-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 - Implantation

Patients admitted for CRT implantation according to current ESC/AHA guidelines

Cardiac Resynchronization Therapy (CRT)

Intervention Type: DEVICE

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.

Group 2 - 6 months control

Patients admitted for 6 months routine checkups of their CRT devices

Cardiac Resynchronization Therapy (CRT)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role: collaborator

Norwegian Health Association

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Espen Remme

Dr.ing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Espen W. Remme, Dr.ing

Role: STUDY_DIRECTOR

Oslo University Hospital

Marit Witso, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Hongxing Luo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Espen W. Remme, Dr.ing

Role: CONTACT

espen.remme@medisin.uio.no

004723071413

Marit Witsø, MD

Role: CONTACT

mhwitso@medisin.uio.no

004723071402

Facility Contacts

Espen W. Remme, Dr.ing

Role: primary

espen.remme@medisin.uio.no

004723071413

Marit Witsø, MD

Role: backup

mhwitso@medisin.uio.no

004723071402

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

218564

Identifier Type: -

Identifier Source: org_study_id