Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05719454 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Novel Setup Algorithm for Cardiac Neuromodulation Therapy

Study acronym: CS-10
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 15 words
    • Site details revised at 3 of 7 sites
  2. Primary completion date: Jul 31, 2024 to Jan 31, 2027
    • Study completion date: Oct 31, 2024 to Feb 28, 2028
    • Study description expanded, about 3 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 7
    • Start date changed from estimate of Apr 1, 2023 to Jun 21, 2023
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
After meeting all inclusion/exclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume. The ambulatory data will provide the basis for a lasting CNT programming by week 8. Follow up visits will be scheduled after 3, 6, and 12 months.
Trial Details
NCT Number NCT05719454
Lead Sponsor BackBeat Medical Inc
Conditions
(from sponsor)		 Hypertension, Bradycardia
Related terms Bradycardia, Hypertension
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov