RecruitingNot ApplicableNCT05814263

HIS Alternative II - UK Site

Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With Symptomatic Heart Failure Despite Optimal Medical Treatment and ECG With Typical Left Bundle Branch Block


Sponsor

Imperial College Healthcare NHS Trust

Enrollment

40 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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 an ECG with a typical left bundle branch block pattern.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

Interventions

DEVICEHIS/LBB pacing

3830 lead to HIS or LBB

DEVICELV pacing

LV lead in a CS branch


Locations(1)

Hammersmith Hospital

London, United Kingdom

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NCT05814263


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