Novel Setup Algorithm for Cardiac Neuromodulation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBackBeat Medical Inc
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 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.
Eligibility criteria
Qualifiers
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 drugs, which is planned to be maintained without changes for a period of at least 2 months post implant.
Subject has an office systolic blood pressure (oSBP) ≥140 and <180 mmHg
Disqualifiers
1. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma)
Subject has permanent atrial fibrillation
Subject has intermittent paroxysmal atrial fibrillation/flutter with significant burden (i.e., >10% atrial fibrillation/flutter beats if available.
Subject has an ejection fraction <50%
Trial design
Treatments tested in this trial
- CNT testing
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov