Evaluating a non-invasive method for cardiac resynchronization therapy
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Oslo University Hospital · NCT05868616
This study tests a new non-invasive device to see how well cardiac resynchronization therapy works for people with heart failure and left bundle branch block during their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05868616 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with heart failure and left bundle branch block (LBBB) who are undergoing cardiac resynchronization therapy (CRT). It aims to assess the acute effects of CRT using a non-invasive device during implantation and follow-up visits. Additionally, echocardiography will be utilized to visualize changes in heart function when CRT is activated and deactivated. The goal is to improve understanding of CRT effectiveness and identify patients who may not benefit from the therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with LBBB heart failure who are on optimal medical therapy and meet specific echocardiographic criteria.
Not a fit: Patients with ongoing atrial fibrillation or complete atrioventricular block will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient selection for CRT, leading to better outcomes for those with heart failure.
How similar studies have performed: Previous studies have shown varying success with CRT, but this non-invasive evaluation approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Marit Witso, MD — Oslo University Hospital
- Study coordinator: Espen W. Remme, Dr.ing
- Email: espen.remme@medisin.uio.no
- Phone: 004723071413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Pacemaker DDD, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases