HIS Alternative II - UK Site

NCT05814263 | Recruiting

• 1 other identifier: 22HH7978
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 an ECG with a typical left bundle branch block pattern.

Conditions

Heart Failure; Left Bundle-Branch Block

Outcome Measures

Primary Outcomes (2)

• Change in Left ventricular end-systolic volume

  Echocardiographic response after 6 months defined as decrease in left ventricular systolic volume of ≥ 15% of baseline

  6 months

• Success rate of implanting a HIS-bundle lead with capture of the left bundle branch or a LBB-lead with narrowing of QRS

  The success rate of implanting a pacing lead to the HIS-bundle with capture of the left bundle at a threshold \< 2.5 V at 1 ms or implantation of a LBB lead with narrowing of the QRS duration and maintaining this effect at 6 month follow-up

  6 months

Secondary Outcomes (7)

• Change in LVEF and left ventricular chamber dimensions

  6 months

• Change in 6-min hall-walk test

  6 months

• Change in NYHA class

  6 months

• Change in Minnesota Living with Heart Failure score

  6 months

• Shortening of QRS duration

  6 months

Study Arms (2)

HIS/LBB pacing

EXPERIMENTAL

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

Device: HIS/LBB pacing

LV pacing

ACTIVE COMPARATOR

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

Device: LV pacing

Interventions

HIS/LBB pacing DEVICE

3830 lead to HIS or LBB

HIS/LBB pacing

LV pacing DEVICE

LV lead in a CS branch

LV pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Hammersmith Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Keene, MBChB

CONTACT

020 3313 1000; daniel.keene@nhs.net

mohamed zuhair, MBBS

CONTACT

020 3313 1000; m.zuhair@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the staff performing and evaluating echocardiography and hall-walk tests are blinded to the treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 14, 2023
• Study Start: December 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 6 months following final recruitment

Locations

GB (1)