Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

NCT05868616 | Recruiting FDA Device

• 1 other identifier: 218564
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reverse remodelling at 6 months follow-up

  Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography

  6 months

Secondary Outcomes (6)

• Hospitalization

  2 years

• Mortality

  2 years

• New York Heart Association (NYHA) Functional Classification

  2 years

• Minnesota Living with Heart Failure Questionnaire

  2 years

• Packer clinical composite score

  2 years

Study Arms (2)

Group 1 - Implantation

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

Device: Cardiac Resynchronization Therapy (CRT)

Group 2 - 6 months control

Patients admitted for 6 months routine checkups of their CRT devices

Device: Cardiac Resynchronization Therapy (CRT)

Interventions

Cardiac Resynchronization Therapy (CRT) 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 1 - Implantation; Group 2 - 6 months control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for CRT implantation according to European Society of Cardiology (ESC) guidelines (2021) or postoperative control at Oslo University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years and \> 80 years;
• Ongoing atrial fibrillation;
• Complete atrioventricular block

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator
• Norwegian Health Association: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0372, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Interventions

Cardiac Resynchronization Therapy

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Espen W. Remme, Dr.ing

  Oslo University Hospital

  STUDY DIRECTOR

• Marit Witso, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Hongxing Luo, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Espen W. Remme, Dr.ing

CONTACT

004723071413; espen.remme@medisin.uio.no

Marit Witsø, MD

CONTACT

004723071402; mhwitso@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.ing

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 22, 2023
• Study Start: March 21, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2031
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

NO (1)