Improving heart failure outcomes with targeted lead positioning in CRT
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
This study is testing if placing a special heart device lead in a more targeted way can help people with heart failure feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Aalborg and 4 other locations) |
| Trial ID | NCT03280862 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether electric targeted left ventricular lead positioning can enhance outcomes for patients suffering from heart failure and prolonged QRS. The study involves the implantation of a cardiac resynchronization therapy (CRT) device, which may include an implantable cardioverter defibrillator (ICD), in patients who have not responded adequately to optimized medical treatment. By focusing on precise lead placement, the trial aims to improve the effectiveness of CRT in patients with reduced left ventricular function and bundle branch block. The study will evaluate the impact of this approach on patient longevity, quality of life, and heart failure symptoms.
Who should consider this trial
Good fit: Ideal candidates include heart failure patients with NYHA class II or III, LVEF ≤ 35%, and bundle branch block who are on optimal medical treatment.
Not a fit: Patients with NYHA class I heart failure or those with a life expectancy of less than 2 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the effectiveness of CRT for heart failure patients, leading to better health outcomes.
How similar studies have performed: Previous studies have shown varying success with CRT, but this targeted lead positioning approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aalborg and 4 other locations
- Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Gentofte University Hospital — Gentofte, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Jens C Nielsen — Aarhus University Hospital
- Study coordinator: Jens C Nielsen
- Email: jenniels@rm.dk
- Phone: +45 40188448
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.