His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction

NCT ID: NCT04529577

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2025-12-01

Brief Summary

The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.

Detailed Description

Patients with reduced systolic ejection fraction (40≤ ejection fraction ≤55%) and pacemaker indication due to high degree AV block are included. The study has a randomized double blinded crossover design. Patients are implanted with a standard right ventricle lead and right atrial lead (if indicated), and in addition a His-bundle lead. Randomization is performed as to which pacing modality is used during the first 6 months. After 6 months the pacing modality is changed. Patients are blinded and endpoint adjudicators, including echocardiography staff, are blinded. Device nurse and physician are not blinded.

Primary endpoint is difference in left ventricular ejection fraction after 6 months, paired comparisons are used and each patient is their own control. Secondary endpoints include complications and safety of the device/electrode, and quality of life.

Conditions

His Bundle Pacing; Heart Failure, Systolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

His-bundle pacing first

Patients are allocated to receive His-bundle pacing for a period of 6 months. Then the patients will cross over to traditional right ventricular (RV) apical pacing for 6 months.

Group Type: EXPERIMENTAL

His-bundle pacing

Intervention Type: DEVICE

A standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated).

A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup.

RV apical pacing first

Patients are allocated to receive traditional RV apical pacing for a period of 6 months. Then the patients will cross over to His-bundle pacing for 6 months.

Group Type: EXPERIMENTAL

His-bundle pacing

Intervention Type: DEVICE

A standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated).

A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup.

Interventions

His-bundle pacing

A standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated).

A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• AV block II or III with high expected pacing need
• Left ventricular ejection fraction between 40% and 55% (inclusive)
• Willing to participate and sign informed consent

Exclusion Criteria

• Under 18 years old
• Pregnant
• Hypertrophic cardiomyopathy
• Cardiac sarcoidosis
• Cardiac amyloidosis
• Previous myocardial infarction within last 3 months
• Ventricular septum defect or other other left ventricular corrective surgery
• Congenital heart disease surgically corrected
• Atrial fibrillation with uncontrolled rate (if not planned for AV node ablation)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rasmus Borgquist, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden

Locations

Skane University Hospital

Lund, , Sweden

Site Status: RECRUITING

Norrland University Hospital

Umeå, , Sweden

Site Status: RECRUITING

Region Hallands Sjukhus Varberg

Varberg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Maiwand Farouq, MD, PhD

Role: CONTACT

maiwand.farouq@skane.se

+ 46 40 336415‬

Rasmus Borgquist, MD

Role: CONTACT

rasmus.borgquist@med.lu.se

+46 46 171010

Facility Contacts

Rasmus Borgquist

Role: primary

rasmus.borgquist@med.lu.se

+4646171000

Steen Jensen, MD PhD

Role: primary

steen.jensen@medicin.umu.se

Cecilia Rorsman

Role: primary

Cecilia.Rorsman@regionhalland.se

Other Identifiers

HIS-PrEF_study

Identifier Type: -

Identifier Source: org_study_id