Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy (NIME-CRT)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiomyopathies; Pacemaker DDD
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy (CRT)

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Espen W. Remme, Dr.ing; Phone Number: 004723071413; Email: espen.remme@medisin.uio.no
• Study Contact Backup: Name: Marit Witsø, MD; Phone Number: 004723071402; Email: mhwitso@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0372
    • Recruiting
    • Oslo University Hospital
    • Contact: Espen W. Remme, Dr.ing; Phone Number: 004723071413; Email: espen.remme@medisin.uio.no
    • Contact: Marit Witsø, MD; Phone Number: 004723071402; Email: mhwitso@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 - Implantation; Patients admitted for CRT implantation according to current ESC/AHA guidelines	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.
Group 2 - 6 months control; Patients admitted for 6 months routine checkups of their CRT devices	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	all cause hospitalization; heart failure hospitalization defined by symptom, signs and biochemistry (NT-proBNP)	2 years
Mortality	all cause death; sudden cardiac death; cardiovascular death; transplantation	2 years
New York Heart Association (NYHA) Functional Classification	The New York Heart Association (NYHA) functional classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.	2 years
Minnesota Living with Heart Failure Questionnaire	Minnesota living with heart failure questionnaire is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life.	2 years
Packer clinical composite score	The Packer clinical composite score classifies each patient into 1 of 3 categories (improved, worsened, unchanged), and is determined using clinical outcomes (hospitalizations, death, heart transplant), heart failure status, and patient symptoms (defined by a higher New York Heart Association (NYHA) functional classification and quality of life measured using the Minnesota Living With Heart Failure Questionnaire). Each endpoint will be assessed at 6, 12, 18, and 24 months.	2 years
6 minute walk test	The 6 minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The test will be performed in group 1 before implantation and at 6 months control to evaluate response to intervention.	6 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: South-Eastern Norway Regional Health Authority; Norwegian Health Association
• Investigators: Study Director: Espen W. Remme, Dr.ing, Oslo University Hospital; Principal Investigator: Marit Witso, MD, Oslo University Hospital; Principal Investigator: Hongxing Luo, MD, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies
• Other Study ID Numbers: 218564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No