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Compares two heart pacing methods in heart failure patients needing a pacemaker

Tests conduction system pacing against standard pacing in adults with heart failure and slow heartbeats.

Plain-language title generated from the registry record
Registry title: Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication

Key facts

Where
Edegem, BelgiumSee the site

Where in Belgium

  • Universitair Ziekenhuis AntwerpenEdegem, BelgiumTaking people

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Trial details

Who runs it
University Hospital, Antwerp
Trial code
NCT06278844
Record updated
26 February 2024
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: 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 ; Age under 18 years old; Pregnancy; Inability to provide consent or to undergo follow-up.

ClinicalTrials.gov NCT06278844