Improving symptoms in patients with first-degree heart block using physiologic pacing
Physiologic Pacing for Symptomatic First-Degree Heart Block
This study is testing whether a new pacing method can help people with first-degree heart block feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ascension Health Industry-sponsored |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06245304 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of physiologic pacing in alleviating symptoms and improving outcomes for patients diagnosed with symptomatic first-degree heart block, characterized by a PR interval of 250ms or more. Participants will be randomized to receive either DDD-50 pacing or Managed Ventricular Pacing (MVP-50) after undergoing left bundle pacing with a Medtronic pacemaker. The study will assess patient symptoms, exercise capacity, arrhythmia burden, and activity levels at baseline, 3 months, and 6 months post-implantation. This comparative effectiveness approach utilizes FDA-approved devices to determine the best pacing strategy for these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a PR interval of 250ms or more and a ventricular ejection fraction greater than 50%.
Not a fit: Patients with permanent atrial fibrillation or those unable to perform a 6-minute walk test may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved symptom management and quality of life for patients with symptomatic first-degree heart block.
How similar studies have performed: Other studies have shown promise in using physiologic pacing for heart block, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Nashville, Tennessee
- Ascension Saint Thomas Midtown — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Daniel Kaiser, MD
- Email: daniel.kaiser@ascension.org
- Phone: 6153295144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.