Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac Resynchronization Therapy (CRT).
- Who it may be relevant to
- Registry conditions: Heart Failure, Pacemaker DDD, Cardiomyopathies, Heart Diseases. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Reverse remodelling at 6 months follow-up [Time frame: 6 months]
Secondary outcome measures (6)
- Hospitalization [Time frame: 2 years]
- Mortality [Time frame: 2 years]
- New York Heart Association (NYHA) Functional Classification [Time frame: 2 years]
- Minnesota Living with Heart Failure Questionnaire [Time frame: 2 years]
- Packer clinical composite score [Time frame: 2 years]
- 6 minute walk test [Time frame: 6 months]
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:
- 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.
Exclusion criteria
- Age < 18 years and > 80 years;
- Ongoing atrial fibrillation;
- Complete atrioventricular block
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT05868616 · 218564