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NCT06278844Recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
75 (estimated)
First submitted
7 Feb 2024
Start date
12 Dec 2023
Primary completion date
Sept 2026
Lead sponsor
University Hospital, Antwerp
NCT number
NCT06278844

What you commit to

  • Study type: Interventional
  • Planned participants: 75
  • From 12 Dec 2023 to the primary completion date, Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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 ...

Lab values

  • 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

  • Age under 18 years old

Other

  • Pregnancy
  • Inability to provide consent or to undergo follow-up

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Antwerpen
Coordinator of this site? Confirm its status
EdegemBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.