Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05462405 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Evaluation of Sympathetic Activity Effects by the BackBeat Medical Cardiac Neuromodulation Therapy (CNT).

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 2023 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2023 to May 2027
    • Site details revised
    v6
  2. Start date changed from estimate of Dec 2022 to Dec 10, 2022v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2022 to Dec 2022
    • Site details revised
    v4
  4. Start date: Sep 2022 to Nov 2022v3
  5. Secondary endpoint revisedv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Measurement and recording of Muscle Sympathetic Neural Activity (MSNA) using microneurography, will be applied to subjects who have been already implanted with a Moderato IPG delivering the BackBeat CNT and/or pacing signals. Several tests will be performed by experienced professionals to ensure the acquired sympathetic nerve signals arise from the targeted nerve source. The Moderato Programmer will be then used to program different sets of CNT for several minutes with a several minutes interval between delivery periods. This delivery pattern is used will allow to acquire sympathetic nerve signals with and without CNT. Subject blood pressure, respiration and ECG data will be collected and recorded, both for safety and for evaluation of CNT dependent secondary indicators of sympathetic activity.
Trial Details
NCT Number NCT05462405
Lead Sponsor BackBeat Medical Inc
Conditions
(from sponsor)		 Hypertension
Related terms Hypertension
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov