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Heart FailureNCT03280862

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

A study testing Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator in people with Heart Failure and Branch Block, Bundle, run by Aarhus University Hospital at 5 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure, Branch Block, Bundle
What is being tested?
Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
5 sitesDenmark
Study dates
20 Mar 2018to 27 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Sinus rhythm or atrial fibrillation
  • Life expectancy >2 years
  • Signed informed consent

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Denmark5 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Gentofte University Hospital

    Gentofte Municipality, 2900

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: 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.

Read more

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.

Being tested
Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator
Keywords
Heart Failure, Branch Block, Cardiac Resynchronization Therapy
Medical subject headings
Heart Failure, Bundle-Branch Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Implantation of CRT-P/-D device

Study groups in NCT03280862
Study groupRoleWhat they receive
ControlActive comparatorImplantation 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
Receives: Device: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator
InterventionExperimentalImplantation 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
Receives: Device: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death or first non-planned hospitalisation for heart failure

    Time to death or first non-planned hospitalisation for heart failure

    Measured: All patients will be followed until the last included patient has been followed for two years

Secondary outcomes (30)

  1. Death

    Time to death

    Measured: All patients will be followed until the last included patient has been followed for two years

  2. Non-planned hospitalisation for heart failure

    Time to first non-planned hospitalisation for heart failure

    Measured: All patients will be followed until the last included patient has been followed for two years

  3. Sudden death

    Time to sudden death

    Measured: All patients will be followed until the last included patient has been followed for two years

  4. Cardiac death

    Time to cardiac death

    Measured: All patients will be followed until the last included patient has been followed for two years

  5. Clinical response

    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)

    Measured: Follow-up at 3, 6, 12, 24 and 48 months

  6. Quality of Life (QoL)

    Changes in score from baseline to follow-up

    Measured: Follow-up at 6, 12, 24 and 48 months

  7. Patient Reported Outcomes (PROs)

    Changes in score from baseline to follow-up

    Measured: Follow-up at 6, 12, 24 and 48 months

  8. Echocardiographic measures of LV function

    Changes from baseline to follow-up in left ventricular ejection fraction (%)

    Measured: Follow-up at 6, 12, 24 and 48 months

  9. Time to first appropriate ICD Therapy

    Time to first appropriate ICD therapy (antitachycardia pacing (ATP) or shock therapy)

    Measured: All patients will be followed until the last included patient has been followed for two years

  10. Time to first inappropriate ICD Therapy

    Time to first inappropriate ICD therapy (antitachycardia pacing (ATP) or shock therapy)

    Measured: All patients will be followed until the last included patient has been followed for two years

  11. Numbers of appropriate ICD Therapies

    Numbers of appropriate ICD therapies (antitachycardia pacing (ATP) or shock therapy)

    Measured: All patients will be followed until the last included patient has been followed for two years

  12. Numbers of inappropriate ICD Therapies

    Numbers of inappropriate ICD therapies (antitachycardia pacing (ATP) or shock therapy)

    Measured: All patients will be followed until the last included patient has been followed for two years

  13. Ventricular tachycardia (VT)/ventricular fibrillation (VF)

    Time to first episode of VT/VF

    Measured: All patients will be followed until the last included patient has been followed for two years

  14. Persistent atrial fibrillation

    Recorded by the implanted device

    Measured: All patients will be followed until the last included patient has been followed for two years

  15. Any atrial fibrillation

    >30 seconds recorded by the implanted device

    Measured: All patients will be followed until the last included patient has been followed for two years

  16. Implantation time

    Procedure time at implantation

    Measured: 0-6 hours, assessed at completion of implantation procedure

  17. Fluoroscopy time

    Fluoroscopy time at implantation in minutes

    Measured: 0-120 minutes, assessed at completion of implantation procedure

  18. Fluoroscopy dose

    Fluoroscopy dose at implantation in mGy

    Measured: Assessed <24 hours after implantation initiation

  19. Equipment used at implantation

    Number of LV leads (0-5) used at implantation

    Measured: Assessed <24 hours after implantation initiation

  20. Device-related outcomes

    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

    Measured: All patients will be followed until the last included patient has been followed for two years

  21. Battery replacements

    Number of device replacements during the study period due to battery depletion

    Measured: All patients will be followed until the last included patient has been followed for two years

  22. Battery longevity estimate

    Measured by actual device battery longevity + estimated remaining device battery longevity as reported by the device at last study follow-up

    Measured: All patients will be followed until the last included patient has been followed for two years

  23. QRS complex width

    Changes in the ECG parameter QRS complex width during follow-up

    Measured: All patients will be followed until the last included patient has been followed for two years

  24. QRS complex morphology

    Changes in the ECG parameter QRS complex morphology during follow-up

    Measured: All patients will be followed until the last included patient has been followed for two years

  25. Predictive value of P-wave

    Predictive value of the baseline ECG parameter P-wave on clinical outcome measures in the entire cohort and between the two treatment groups

    Measured: All patients will be followed until the last included patient has been followed for two years

  26. Predictive value of QRS complex width

    Predictive value of the baseline ECG parameter QRS complex width on clinical outcome measures in the entire cohort and between the two treatment groups

    Measured: All patients will be followed until the last included patient has been followed for two years

  27. Predictive value of QRS complex morphology

    Predictive value of the baseline ECG parameter QRS complex morphology on clinical outcome measures in the entire cohort and between the two treatment groups

    Measured: All patients will be followed until the last included patient has been followed for two years

  28. Changes in cardiac chamber dimensions

    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

    Measured: All patients will be followed until the last included patient has been followed for two years

  29. Changes in left ventricular ejection fraction LVEF

    Changes in cardiac chamber function measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups

    Measured: All patients will be followed until the last included patient has been followed for two years

  30. Changes in right ventricular ejection fraction RVEF

    Changes in cardiac chamber function measured by echocardiography and cardiac CT during follow-up in the entire cohort and between the two treatment groups

    Measured: All patients will be followed until the last included patient has been followed for two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2017
  2. Study start20 Mar 2018
  3. Primary completion27 Feb 2026
  4. Study completion27 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03280862
Sponsor's protocol ID
1-10-72-330-16
Status last verified
May 2026
First submitted
8 Jun 2017
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nielsen JC, Svendsen JH, Johansen JB, Larsen JM, Larroude CE, Poulsen SH, Eiskjaer H, Norgaard BL, Risum N, Kober L, Kristensen J, Ovrehus K, Sommer AM, Schou M, Sogaard P, Poulsen MK, Kofoed KF, Hansen TF, Graff C, Skals RG, Frausing MHJP, Frandsen EA, Jensen JM, Vinther M, Jensen HK, Haarbo J, Zaremba T, Viezelis M, Philbert B, Hjort J, Gerdes C, Kronborg MB; DANISH-CRT Trial Investigators. Targeted left ventricular lead placement in biventricular pacing for heart failure: a national, multicentre, double-blind, randomised controlled trial in Denmark. Lancet. 2026 Aug 31:S0140-6736(26)01597-7. doi: 10.1016/S0140-6736(26)01597-7. Online ahead of print.

    PubMed 42673980

  • Kronborg MB, Frausing MHJP, Svendsen JH, Johansen JB, Riahi S, Haarbo J, Poulsen SH, Eiskjaer H, Kober L, Ovrehus K, Sommer AM, Schou M, Norgaard BL, Risum N, Poulsen MK, Sogaard P, Sandgaard N, Kofoed KF, Hansen TF, Graff C, Pedersen SS, Skals RG, Nielsen JC. Does targeted positioning of the left ventricular pacing lead towards the latest local electrical activation in cardiac resynchronization therapy reduce the incidence of death or hospitalization for heart failure? Am Heart J. 2023 Sep;263:112-122. doi: 10.1016/j.ahj.2023.05.011. Epub 2023 May 21.

    PubMed 37220821

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator in people with Heart Failure and Branch Block, Bundle, run by Aarhus University Hospital at 5 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03280862, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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