NCT05868616 Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
| NCT ID | NCT05868616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-03-21 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-03-21 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Espen W. Remme, Dr.ing
STUDY DIRECTOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT05868616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05868616 currently recruiting?
Yes, NCT05868616 is actively recruiting participants. Contact the research team at espen.remme@medisin.uio.no for enrollment information.
Where is the NCT05868616 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT05868616 clinical trial?
NCT05868616 is sponsored by Oslo University Hospital. The principal investigator is Espen W. Remme, Dr.ing at Oslo University Hospital. The trial plans to enroll 80 participants.
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