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Completed

NCT Number: NCT03280862

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

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Branch Block, Bundle Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Implantation of CRT-P/-D device

Primary outcomes

  1. 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

Secondary outcomes

  1. Death

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

    Time to death

  2. 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

  3. Sudden death

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

    Time to sudden death

  4. Cardiac death

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

    Time to cardiac death

  5. 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)

  6. Quality of Life (QoL)

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

    Changes in score from baseline to follow-up

  7. Patient Reported Outcomes (PROs)

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

    Changes in score from baseline to follow-up

  8. 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 (%)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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

  14. 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

  15. 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

  16. Implantation time

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

    Procedure time at implantation

  17. Fluoroscopy time

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

    Fluoroscopy time at implantation in minutes

  18. Fluoroscopy dose

    Time frame: Assessed <24 hours after implantation initiation

    Fluoroscopy dose at implantation in mGy

  19. Equipment used at implantation

    Time frame: Assessed <24 hours after implantation initiation

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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Gentofte University Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2017
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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