Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication

NCT06278844 | Recruiting FDA Device

• 1 other identifier: 3020
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed.

Conditions

Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction; Heart Conduction Disorder

Keywords

conduction system pacing; exercise capacity; Cardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Change of VO2 peak from baseline to 24 weeks

  24 weeks after pacemaker implantation

Secondary Outcomes (5)

• Exercise capacity

  4 weeks after pacemaker implantation

• Echocardiographic parameters (Ejection Fraction)

  4, 12 and 24 weeks after pacemaker implantation

• QRS width

  4, 12 and 24 weeks after pacemaker implantation

• Biomarker, N-terminal pro B-type natriuretic peptide levels

  4 and 24 weeks after pacemaker implantation

• Health-related quality of life scores

  4,12 and 24 weeks after pacemaker implantation

Study Arms (2)

Conduction system pacing

EXPERIMENTAL

In the conduction system pacing group, the right ventricular lead will be placed in a septal position to achieve conduction system pacing, either His bundle pacing (HBP) or left bundle branch area (LBBA) pacing.

Device: Conduction system pacing

Right ventricular apical pacing

ACTIVE COMPARATOR

Control group, in this group patients will receive a pacemaker with the ventricular lead in the right ventricle apex.

Device: Right ventricular apical pacing

Interventions

Conduction system pacing DEVICE

In the conduction system pacing group, the right ventricular lead will be placed in a septal position to achieve conduction system pacing, either His bundle pacing (HBP) or left bundle branch area (LBBA) pacing. In the usual care group, the right ventricular lead will be placed in the right ventricle apex as usual.

Conduction system pacing

Right ventricular apical pacing DEVICE

This is the usual care group. Patients will receive a pacemaker device with the right ventricular lead inserted in the apex and not in the septal position.

Right ventricular apical pacing

Eligibility Criteria

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

You may qualify if:

• Patients with heart failure as defined by European Society of Cardiology guidelines
• Signs and/or symptoms of heart failure
• AND LVEF \<50% OR LVEF ≥50% and objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised filling pressures
• AND indication for cardiac pacing as defined by European Society of Cardiology guidelines

You may not qualify if:

• Age under 18 years old
• Pregnancy
• Inability to provide consent or to undergo follow-up
• Class 1A indication for classical CRT as defined by European Society of Cardiology guidelines. Patients with a class 2A or higher indication for CRT can be included. However, patients with Class 1A indication for classical CRT but failure or suboptimal result of CS lead placement can be included.
• Significant cardiac or extracardiac comorbidity precluding maximal exercise testing, examples: Recent (\<4 weeks) decompensation of heart failure, angina pectoris class ≥2 , uncontrolled hypertension or arrhythmia , severe valvular heart disease, significant peripheral vascular disease, orthopaedic limitation ...
• Comorbidity that may influence 6-month prognosis, examples:
• Severe chronic kidney disease (eGFR ≤20 mL/kg/min or dialysis) , severe chronic obstructive pulmonary disease (≥GOLD 3) , active malignancy ...

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Gevaert

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Gevaert

CONTACT

038213538; Andreas.gevaert@uza.be

Faro Verelst

CONTACT

038213538; Faro.verelst@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 26, 2024
• Study Start: December 12, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)