NCT04409119Completed
Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical LBBB.
Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With Symptomatic Heart Failure Despite Optimal Medical Treatment and an ECG With a Typical Left Bundle Branch Block Pattern.
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 26 May 2020
- Start date
- Jun 2020
- Primary completion date
- Feb 2026
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Heart failure
- NCT number
- NCT04409119
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From Jun 2020 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Severe renal failure with eGFR \< 30 ml/min
Other
- Existing biventricular pacing system
- Permanent atrial fibrillation
- AMI or CABG within the last three months
- The patient does not want to participate
Who the study is looking for
- Patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with LVEF ≤ 35% assessed by echocardiography, NYHA class II-IV heart failure symptoms despite optimal medical treatment and
- Either planned new implantation of a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block (see definition below)
- Or planned upgrade of an existing pacemaker or ICD to a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block or there has been\> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment
- Signed informed consent
- Typical left bundle branch block:
- QRS width \> 130 msec for women and \> 140 msec for men QS or rS pattern in leads V1 and V2, and mid-QRS plateau phase with or without extras in at least 2 of leads V1, V2, V5, V6, I, and aVL
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.