Status:
ACTIVE_NOT_RECRUITING
Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical LBBB.
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Imperial College Healthcare NHS Trust
Conditions:
Heart Failure
Left Bundle-Branch Block
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Biventricular pacing has for more than a decade been standard of care for patients with HFrEF, LVEF \< 35%, NYHA II-IV despite optimal medical treatment and an ECG with left bundle branch block (LBBB)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Existing biventricular pacing system
- Permanent atrial fibrillation
- Severe renal failure with eGFR \< 30 ml/min
- AMI or CABG within the last three months
- The patient does not want to participate
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04409119
Start Date
June 1 2020
End Date
December 30 2025
Last Update
July 30 2025
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100