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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Hammersmith Hospital
RECRUITING
London
Contact Information
Primary
Daniel Keene, MBChB
daniel.keene@nhs.net
020 3313 1000
Backup
mohamed zuhair, MBBS
m.zuhair@nhs.net
020 3313 1000
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 40
Treatments
Experimental: HIS/LBB pacing
In this arm a right ventricular (RV) lead or implantable cardioverter defibrillator (ICD) lead is placed first and then implantation of a HIS-pacing lead is attempted. If it is not possible to find and pace HIS, to correct the LBBB or the threshold for correcting the LBBB is \> 2.5 V at 1 ms, implantation of a LBB-pacing lead is attempted instead. If that is not possible either, a left ventricular (LV) lead is implanted.~Intervention: Device: HIS/LBB pacing
Active_comparator: LV pacing
In this arm an RV-lead or ICD-lead is placed first and then implantation of a LV-pacing lead is attempted. If this is not possible due to anatomical difficulties (no coronary sinus (CS) access, no available branches other than v cordis anterior or v cordis media) or electrical difficulties (no capture below 4 V at 1.0 msec or phrenic nerve stimulation \< 2x pacing threshold), implantation of a HIS-pacing lead is attempted instead. If that is not possible or the threshold for correcting the LBBB is \> 2.5 V at 1 ms, implantation of a LBB-pacing lead is attempted instead.~Intervention: Device: LV pacing
Related Therapeutic Areas
Sponsors
Leads: Imperial College Healthcare NHS Trust
Collaborators: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov