General Information

Age Group

Adults ages 40 and older

Status

Recruiting

Protocol Number

NCT06678841

Background Information

The purpose of the study is to evaluate the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of HFpEF. Personalized pacing is defined as programming a pacemaker's lower rate to a value based on the patient's LVEF and height.The results from this study may be used to support an indication for a personalized cardiac pacing rate in patients with HFpEF.

For more information, visit: https://clinicaltrials.gov/study/NCT06678841

Offered At

Inova Fairfax Hospital
3300 Gallows Road 
Falls Church, VA 22042
Principal Investigator

Brett Atwater, MD

Eligibility Information

  • Age ≥40 years
  • Documented EF ≥50% within the preceding 12 months
  • Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
  • Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)

Ineligibility Information

  • Improved or recovered EF (i.e., prior LVEF<50%)
  • Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, ICD, CRT)
  • Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction
  • Average heart rate <50 bpm or symptomatic bradycardia