Novel Setup Algorithm for Cardiac Neuromodulation Therapy
Recruiting
N/A
Interventional Study
Hypertension
Bradycardia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- BackBeat Medical Inc · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subject is ≥ 18 years of age
* Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker.
* Subject has stable (for prior 1 month) hypertension treatment with 1, 2 or 3 antihypertensive dru…
Contacts