Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-12-01
2025-01-01
Brief Summary
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Detailed Description
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In the present study the investigators randomize 125 patients in one center to either conventional CRT (45 patients) or HIS/LBB pacing (80 patients). In the HIS/LBB arm, direct HIS-pacing is attempted first but if its not possible or the pacing threshold for capturing the left bundle branch is \> 2.5 V at 1 ms the investigators switch to placing a LBB-lead.
Power calculation for non-inferiority: With the 50 patients in the first His Alternative study (25 Biv-CRT og 25 His-CRT) the investigators observed a fall in systolic volumes of 34% and 46% with a standard deviation of 13-16%. Using these numbers it would take at least 108 patients to be 90% sure that the lower limit of a one-sided 97.5% confidence interval (equal to a 95% two-sided confidence interval) would be over the non-inferiority limit of -10%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
HIS/LBB pacing
3830 lead to HIS or LBB
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
LV pacing
LV lead in a CS branch
Interventions
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HIS/LBB pacing
3830 lead to HIS or LBB
LV pacing
LV lead in a CS branch
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Imperial College Healthcare NHS Trust
OTHER
Responsible Party
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Locations
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Hammersmith Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Daniel Keene
Role: primary
Other Identifiers
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22HH7978
Identifier Type: -
Identifier Source: org_study_id
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