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

May 27, 2026 updated by: Jens Cosedis Nielsen, Aarhus University Hospital

Does Targeted LV Lead Positioning Towards Latest Local Electric Activation at CRT Implantation Reduce Incidence of the Combined Endpoint "Death or Non-planned Hospitalisation for Heart Failure (HF)" in Patients With HF and Prolonged QRS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jens C Nielsen
  • Phone Number: +45 40188448
  • Email: jenniels@rm.dk

Study Contact Backup

  • Name: Henriette Holmberg
  • Phone Number: +45 7845 2115
  • Email: henrholm@rm.dk

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Gentofte Municipality, Denmark, 2900
        • Gentofte University Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Device: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator
Implantation of CRT-P/-D device
Experimental: 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
Device: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator
Implantation of CRT-P/-D device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Death or first non-planned hospitalisation for heart failure
Time Frame: All patients will be followed until the last included patient has been followed for two years
Time to death or first non-planned hospitalisation for heart failure
All patients will be followed until the last included patient has been followed for two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Death
Time Frame: All patients will be followed until the last included patient has been followed for two years
Time to death
All patients will be followed until the last included patient has been followed for two years
Non-planned hospitalisation for heart failure
Time Frame: All patients will be followed until the last included patient has been followed for two years
Time to first non-planned hospitalisation for heart failure
All patients will be followed until the last included patient has been followed for two years
Sudden death
Time Frame: All patients will be followed until the last included patient has been followed for two years
Time to sudden death
All patients will be followed until the last included patient has been followed for two years
Cardiac death
Time Frame: All patients will be followed until the last included patient has been followed for two years
Time to cardiac death
All patients will be followed until the last included patient has been followed for two years
Clinical response
Time Frame: Follow-up at 3, 6, 12, 24 and 48 months
Increase in New York Heart Association (NYHA) class (≥1 class from baseline) or improved walking distance by six-minute walk test (6MWT) (≥10% from baseline)
Follow-up at 3, 6, 12, 24 and 48 months
Quality of Life (QoL)
Time Frame: Follow-up at 6, 12, 24 and 48 months
Changes in score from baseline to follow-up
Follow-up at 6, 12, 24 and 48 months
Patient Reported Outcomes (PROs)
Time Frame: Follow-up at 6, 12, 24 and 48 months
Changes in score from baseline to follow-up
Follow-up at 6, 12, 24 and 48 months
Echocardiographic measures of LV function
Time Frame: Follow-up at 6, 12, 24 and 48 months
Changes from baseline to follow-up in left ventricular ejection fraction (%)
Follow-up at 6, 12, 24 and 48 months
Time to first appropriate ICD Therapy
Time Frame: All patients will be followed until the last included patient has been followed for two years
Time to first appropriate ICD therapy (antitachycardia pacing (ATP) or shock therapy)
All patients will be followed until the last included patient has been followed for two years
Time to first inappropriate ICD Therapy
Time Frame: All patients will be followed until the last included patient has been followed for two years
Time to first inappropriate ICD therapy (antitachycardia pacing (ATP) or shock therapy)
All patients will be followed until the last included patient has been followed for two years
Numbers of appropriate ICD Therapies
Time Frame: All patients will be followed until the last included patient has been followed for two years
Numbers of appropriate ICD therapies (antitachycardia pacing (ATP) or shock therapy)
All patients will be followed until the last included patient has been followed for two years
Numbers of inappropriate ICD Therapies
Time Frame: All patients will be followed until the last included patient has been followed for two years
Numbers of inappropriate ICD therapies (antitachycardia pacing (ATP) or shock therapy)
All patients will be followed until the last included patient has been followed for two years
Ventricular tachycardia (VT)/ventricular fibrillation (VF)
Time Frame: All patients will be followed until the last included patient has been followed for two years
Time to first episode of VT/VF
All patients will be followed until the last included patient has been followed for two years
Persistent atrial fibrillation
Time Frame: All patients will be followed until the last included patient has been followed for two years
Recorded by the implanted device
All patients will be followed until the last included patient has been followed for two years
Any atrial fibrillation
Time Frame: All patients will be followed until the last included patient has been followed for two years
>30 seconds recorded by the implanted device
All patients will be followed until the last included patient has been followed for two years
Implantation time
Time Frame: 0-6 hours, assessed at completion of implantation procedure
Procedure time at implantation
0-6 hours, assessed at completion of implantation procedure
Fluoroscopy time
Time Frame: 0-120 minutes, assessed at completion of implantation procedure
Fluoroscopy time at implantation in minutes
0-120 minutes, assessed at completion of implantation procedure
Fluoroscopy dose
Time Frame: Assessed <24 hours after implantation initiation
Fluoroscopy dose at implantation in mGy
Assessed <24 hours after implantation initiation
Equipment used at implantation
Time Frame: Assessed <24 hours after implantation initiation
Number of LV leads (0-5) used at implantation
Assessed <24 hours after implantation initiation
Device-related outcomes
Time Frame: All patients will be followed until the last included patient has been followed for two years
Periprocedural: lead re-operation, pneumothorax, hemothorax, pericardial bleeding/tamponade and later (30 days post implantation): LV lead re-operation, device replacement due to battery depletion, and infection requiring extraction
All patients will be followed until the last included patient has been followed for two years
Battery replacements
Time Frame: All patients will be followed until the last included patient has been followed for two years
Number of device replacements during the study period due to battery depletion
All patients will be followed until the last included patient has been followed for two years
Battery longevity estimate
Time Frame: All patients will be followed until the last included patient has been followed for two years
Measured by actual device battery longevity + estimated remaining device battery longevity as reported by the device at last study follow-up
All patients will be followed until the last included patient has been followed for two years
QRS complex width
Time Frame: All patients will be followed until the last included patient has been followed for two years
Changes in the ECG parameter QRS complex width during follow-up
All patients will be followed until the last included patient has been followed for two years
QRS complex morphology
Time Frame: All patients will be followed until the last included patient has been followed for two years
Changes in the ECG parameter QRS complex morphology during follow-up
All patients will be followed until the last included patient has been followed for two years
Predictive value of P-wave
Time Frame: All patients will be followed until the last included patient has been followed for two years
Predictive value of the baseline ECG parameter P-wave on clinical outcome measures in the entire cohort and between the two treatment groups
All patients will be followed until the last included patient has been followed for two years
Predictive value of QRS complex width
Time Frame: All patients will be followed until the last included patient has been followed for two years
Predictive value of the baseline ECG parameter QRS complex width on clinical outcome measures in the entire cohort and between the two treatment groups
All patients will be followed until the last included patient has been followed for two years
Predictive value of QRS complex morphology
Time Frame: All patients will be followed until the last included patient has been followed for two years
Predictive value of the baseline ECG parameter QRS complex morphology on clinical outcome measures in the entire cohort and between the two treatment groups
All patients will be followed until the last included patient has been followed for two years
Changes in cardiac chamber dimensions
Time Frame: All patients will be followed until the last included patient has been followed for two years
Volumes of cardiac chambers (left ventricle, left atrium, right ventricle, right atrium) measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups
All patients will be followed until the last included patient has been followed for two years
Changes in left ventricular ejection fraction LVEF
Time Frame: All patients will be followed until the last included patient has been followed for two years
Changes in cardiac chamber function measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups
All patients will be followed until the last included patient has been followed for two years
Changes in right ventricular ejection fraction RVEF
Time Frame: All patients will be followed until the last included patient has been followed for two years
Changes in cardiac chamber function measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups
All patients will be followed until the last included patient has been followed for two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital
Rigshospitalet, Denmark
Aalborg University Hospital
Gentofte University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jens C Nielsen, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-330-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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