Physiologic Pacing for Symptomatic First-Degree Heart Block

Launched by ASCENSION HEALTH · Jan 29, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called physiologic pacing to see if it can help people with symptomatic first-degree heart block, a condition where the heart's electrical signals are slowed down, leading to symptoms like fatigue and dizziness. The goal is to find out if this new pacing method can improve patients' symptoms and overall health. The study is currently looking for participants aged 18 and older who have a specific heart function and heart rhythm pattern, and who are experiencing moderate to severe symptoms.

To be eligible, participants should have a heart function (measured as Ventricular Ejection Fraction) greater than 50% and a PR interval of 250 milliseconds or longer, which indicates the slow electrical signaling. Patients with certain conditions, such as permanent atrial fibrillation or serious health issues that limit their life expectancy, cannot join the trial. If you decide to participate, you can expect regular check-ups and monitoring to see how the treatment affects your symptoms and heart function. This study is important as it could lead to better treatments for people with this heart condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 or above
• • Ventricular Ejection Fraction (EF) \> 50%
• • New York Heart Association (NYHA) class II-IV
• • PR interval ≥250ms
• • Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm
• Exclusion Criteria:
• • Permanent atrial fibrillation (AF)
• • Patients who are unable to perform a 6 minute hall walk
• • Other serious medical condition with life expectancy of less than 1 year
• • Lack of capacity to consent
• • Pregnancy
• • Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)