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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
CNT testing
DeviceThe effect of CNT on blood pressure will be obtained throughout the year long follow up period.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: CNT Setup Algorithm Version 1Experimental treatment 1 intervention
Group B: CNT Setup Algorithm Version 2Experimental treatment 1 intervention
Group C: CNT therapy optimization without use of the Setup AlgorithmOther 1 intervention
Trial outcomes
Primary outcomes
1
CNT efficacy: Changes in average 24 hour systolic ambulatory blood pressure
The change in the 24 hr blood pressure recording after each of the two set up sessions (week 4 and week 6) will be compared to the 24 hr ambulatory data of the control (week 3).
Time frame
up to 12 Month follow-up visit2
CNT safety: Incidence of device- and treatment-related adverse and serious adverse
Incidence of device- and treatment-related adverse and serious adverse events during the study.
Time frame
up to 12 Month follow-up visitSponsors and contacts
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Source ClinicalTrials.gov