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Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

ConditionsHeart FailurePacemaker DDDCardiomyopathiesHeart DiseasesCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorOslo University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age < 18 years and > 80 years;

Ongoing atrial fibrillation;

Complete atrioventricular block

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group 1 - Implantation1 intervention
Group B: Group 2 - 6 months control1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

Hospitalization

* all cause hospitalization * heart failure hospitalization defined by symptom, signs and biochemistry (NT-proBNP)

Time frame
2 years
2

Mortality

* all cause death * sudden cardiac death * cardiovascular death * transplantation

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oslo University Hospital

Lead sponsor

South-Eastern Norway Regional Health Authority

Collaborator

Norwegian Health Association

Collaborator

Source ClinicalTrials.gov
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