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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03280862
Other study ID # 1-10-72-330-16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2018
Est. completion date June 30, 2026

Study information

Verified date January 2024
Source Aarhus University Hospital
Contact Jens C Nielsen
Phone +45 40188448
Email jenniels@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator
Implantation of CRT-P/-D device

Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg
Denmark Aarhus University Hospital Aarhus
Denmark Rigshospitalet Copenhagen
Denmark Gentofte University Hospital Gentofte
Denmark Odense University Hospital Odense

Sponsors (5)

Lead Sponsor Collaborator
Aarhus University Hospital Aalborg University Hospital, Gentofte University Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death or first non-planned hospitalisation for heart failure 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 Death Time to death All patients will be followed until the last included patient has been followed for two years
Secondary Non-planned hospitalisation for heart failure 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
Secondary Sudden death Time to sudden death All patients will be followed until the last included patient has been followed for two years
Secondary Cardiac death Time to cardiac death All patients will be followed until the last included patient has been followed for two years
Secondary 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) Follow-up at 3, 6, 12, 24 and 48 months
Secondary Quality of Life (QoL) Changes in score from baseline to follow-up Follow-up at 6, 12, 24 and 48 months
Secondary Patient Reported Outcomes (PROs) Changes in score from baseline to follow-up Follow-up at 6, 12, 24 and 48 months
Secondary Echocardiographic measures of LV function Changes from baseline to follow-up in left ventricular ejection fraction (%) Follow-up at 6, 12, 24 and 48 months
Secondary Time to first appropriate ICD Therapy 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
Secondary Time to first inappropriate ICD Therapy 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
Secondary Numbers of appropriate ICD Therapies 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
Secondary Numbers of inappropriate ICD Therapies 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
Secondary Ventricular tachycardia (VT)/ventricular fibrillation (VF) Time to first episode of VT/VF All patients will be followed until the last included patient has been followed for two years
Secondary Persistent atrial fibrillation Recorded by the implanted device All patients will be followed until the last included patient has been followed for two years
Secondary Any atrial fibrillation >30 seconds recorded by the implanted device All patients will be followed until the last included patient has been followed for two years
Secondary Implantation time Procedure time at implantation 0-6 hours, assessed at completion of implantation procedure
Secondary Fluoroscopy time Fluoroscopy time at implantation in minutes 0-120 minutes, assessed at completion of implantation procedure
Secondary Fluoroscopy dose Fluoroscopy dose at implantation in mGy Assessed <24 hours after implantation initiation
Secondary Equipment used at implantation Number of LV leads (0-5) used at implantation Assessed <24 hours after implantation initiation
Secondary 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 All patients will be followed until the last included patient has been followed for two years
Secondary Battery replacements 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
Secondary Battery longevity estimate 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
Secondary QRS complex width 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
Secondary QRS complex morphology 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
Secondary 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 All patients will be followed until the last included patient has been followed for two years
Secondary 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 All patients will be followed until the last included patient has been followed for two years
Secondary 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 All patients will be followed until the last included patient has been followed for two years
Secondary 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 All patients will be followed until the last included patient has been followed for two years
Secondary 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 All patients will be followed until the last included patient has been followed for two years
Secondary 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 All patients will be followed until the last included patient has been followed for two years
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