DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Heart failure is a leading cause of morbidity and mortality. Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with symptomatic heart failure in spite of optimised medical treatment (OMT), reduced left ventricular pump function with left ventricular ejection fraction (LVEF) ≤ 35% and prolonged activation of the ventricles (bundle branch block: BBB). CRT is established by implanting an advanced pacemaker system with three leads in the right atrium, right ventricle, and in the coronary sinus (CS) for pacing the left ventricle (LV), and often is combined with an implantable defibrillator (ICD) function. On average, CRT treatment improves longevity, quality of life and functional class, and reduces heart failure symptoms. Thus, at present, CRT is indicated for heart failure patients on OMT with BBB or chronic right ventricular (RV) pacing.

It is, however, a significant problem that 30-40% of CRT patients do not benefit measurably - showing symptomatic improvement or improved cardiac pump function - from this therapy (socalled non-responders). LV lead placement is one of the major determinants of beneficial effect from CRT.

Observational studies and three randomised trials with small sample sizes indicate that targeted placement of the LV lead towards a late activated segment of the LV may be associated with improved outcome. Based on this literature, some physicians already search for late activation when positioning the LV lead. However, such a strategy was never tested in a controlled trial with a sample size sufficient to investigate important clinical outcomes. Detailed mapping for a late activation may increase operating times and infection risk, result in use of more electrodes and wires, thereby increasing costs, and increase radiation exposure for patient and staff. Placement of the LV lead in late activated areas close to myocardial scar may even result in higher risk of arrhythmia and death.

At present, it is completely unsettled whether targeted positioning of the LV lead to the latest electrically activated area of LV is superior to contemporary standard CRT with regard to improving prognosis for patients with heart failure and BBB.

The present study aims to test whether targeting the placement of the LV lead towards the latest electrically activated segment in the coronary sinus branches improves outcome as compared with standard LV lead implant in a patient population with heart failure and CRT indication.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electrophysiological Optimization of Left Ventricular Lead Placement in CRT

NCT02346097

Congestive Heart Failure

COMPLETED NA

Resynchronization/Defibrillation for Ambulatory Heart Failure Trial

NCT00251251

Heart Failure, Congestive

COMPLETED NA

Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy

NCT01323686

Heart Failure

COMPLETED NA

Ensure Cardiac Resynchronization Therapy Study

NCT00291564

Heart Failure

COMPLETED

Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment

NCT01426321

Heart Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Branch Block, Bundle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind randomised controlled trial. Patients are included and randomised 1:1 into two groups for implantation of either

1. a CRT-D/P device with the LV lead positioned according to the latest electrical activation in the CS (intervention group) or
2. a CRT-D/P device with the LV lead positioned preferentially in a posterolateral, non-apical position (control group)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Patients are unaware of treatment arm. All patients undergo the same pre-implant program and follow-up. Healthcare personel performing follow-up are blinded for treatment arm. Outcome events are evaluated by a committee blinded for treatment arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator with the LV lead positioned preferentially in a posterolateral, non-apical position

Group Type ACTIVE_COMPARATOR

Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator

Intervention Type DEVICE

Implantation of CRT-P/-D device

Intervention

Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator with the LV lead positioned according to the latest electrical activation in the CS

Group Type EXPERIMENTAL

Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator

Intervention Type DEVICE

Implantation of CRT-P/-D device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator

Implantation of CRT-P/-D device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Heart Failure, NYHA II, III, outpatient IV
* LVEF ≤35% measured by echocardiography
* Optimal medical treatment for heart failure
* Bundle Branch Block
* Indication for primary CRT-D or CRT-P implantation or upgrade from RV pacing (pacemaker or ICD) to CRT-D or CRT-P
* Ischemic heart disease (IHD) or non-IHD
* Sinus rhythm or atrial fibrillation
* Life expectancy \>2 years
* Signed informed consent

Exclusion Criteria

* NYHA class I
* Acute mycardial infarction (AMI) within the latest 3 months
* Coronary artery bypass graft (CABG) within the latest 3 months
* Life expectancy \<2 years
* Participation in another clinical trial of experimental treatment
* Contraindication for establishing implantable device treatment
* Previously implanted CRT system
* Does not wish to participate

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No