Restoration of Chronotropic Competence in Heart Failure Patients with Normal Ejection Fraction (RESET)

Status: Currently enrolling patients

RESET is a pioneering effort that is exploring a device-based therapy solution for a population of heart failure (HF) patients with a preserved or normal EF, who currently have limited treatment options.


RESET is an ongoing trial and has not yet published results.


  • Patients are stratified into two groups according to βB usage.
  • Patients are evaluated for implant eligibility.
  • Patients meeting screening criteria will be implanted.
  • Therapy evaluated for each patient in a randomized order paired fashion at 1 month visits A & B.
  • Pacing therapy will be evaluated again at 6 months.
  • Patient clinical status and device will be assessed at 12 months.

Patient Population

Eligible study participants included both male and female patients, 18 years or older, that are NYHA Class II-III with an (EF) > 50%, and exhibit chronotropic incompetence.

Some of the exclusion criteria were:

  • AFib or flutter 90 days prior to enrollment
  • Primary pulmonary disease
  • HCM or infiltrative cardiomyopathy
  • Experienced unstable agina, MI, or undergone CABG or PTCA 60 days prior to enrollment
  • Moderate or greater valve disease, repair or replacement
  • Condition preventing exercise testing

Approximately 30 Centers in the U.S.
76 patients will be implanted

  • 38 patients on βBs & 38 patients not on βBs 

Clinical Relevance

  • To evaluate the effect of rate-adaptive pacing (RAP) therapy on functional capacity in patients with HF and a preserved EF
  • Primary endpoint: peak oxygen uptake (pVO2)
  • Secondary endpoint: quality of life (QoL)
  • RESET is the first multicenter device based therapy trial undertaken in patients with HF and a preserved EF aimed at improving exertional tolerance and QoL