Cardiac Neuromodulation Therapy (CNT) "Washout" Sub-Study

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    28
  • sponsor
    BackBeat Medical Inc
Updated on 25 March 2022

Summary

This washout protocol is structured as a sub-study for patients willing to participate after finishing the double blind randomised phase of the clinical trial, NCT02837445. Devices will be turned off for a week approximately. Patients will have their PHC programmed to automatically turn off 24 hr after a medical and technical visit and remain in regular pacing. Ambulatory recording of the BP will start at the end of the visit, and continue for 24 hr after the turn off time (48 hr recording). Conversely, patients will return at the end of the first week, when a second 48 hr recording will be initiated, this time, the PHC will be programmed to turn on 24 hr later. The recordings therefore will provide data of the ON to OFF transition for the evaluation of the residual effect of PHC after 24 h and after week.

Description

As detailed in protocol CS-03, the BackBeat Moderato system applies standard pacing signals according to a specially timed, alternating sequence short and longer atrioventricular (AV) delays, to reduce blood pressure as a treatment for hypertension. The algorithm that governs the delivery of these pacing signals is referred to as Cardiac Neuromodulation Therapy (CNT) and the signals are referred to as Programable Hypertension Control (PHC) signals, (refer to Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial, NCT02837445) As currently used, CNT requires continuous right ventricle (RV) pacing. However, due to potentially long-term effects of CNT on baroceptor function, intermittent deactivation of CNT could reduce the overall amount of pacing without loss of efficacy. Support for this hypothesis comes from a preclinical testing of CNT that was detailed in "Chapter II - Pre-Clinical Testing" of the approved Investigator Brochure. BackBeat Medical conducted a chronic feasibility study in 4 dogs with hypertension induced by renal artery banding which were implanted with a Moderato IPG for 4 months. Results from this study showed that when CNT was turned off after 30 days of continuous CNT, there was a very slow increase in systolic pressure, approaching pre-therapy levels only several weeks later. A 50% residual effect remained at 20 days, with a total washout period of approximately 30 days.

One possible explanation for this observation is that the signal beneficially changes the pressure"set point" of the baroceptor reflexes. Changes in the set point could result from changes at the level of either the pressure sensor in the carotid sinus or within the pressure regulatory region of the central nervous system; namely the nucleus tractus solitarius (NTS) in the medulla oblongata.

This sub-study aims to evaluate whether and for how long the blood-pressure lowering effect of CNT persists following its cessation in patients who have been treated with CNT for a prolonged period of time.

Details
Condition Hypertension,Essential, Systolic Hypertension
Treatment Programmable Hypertension Control (BackBeat Moderato), Pacing (BackBeat Moderato)
Clinical Study IdentifierNCT05086523
SponsorBackBeat Medical Inc
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is implanted with a Moderato implantable pulse generator (IPG) and completed participation in the CS-03 clinical study
Subject has been treating with continuous, active CNT pacing signals for at least
month
Subject's CNT signal parameters have been stable for at least 1 month
Subject has an average office systolic blood pressure less than 170 mmHg at the sub-study screening visit (with CNT on)

Exclusion Criteria

Subject has permanent atrial fibrillation
Subject had significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats) in the past month. Atrial fibrillation/flutter burden will be determined by interrogation of the Moderato pulse generator
Subject experienced a neurological events (stroke or TIA) within the past year Subject have had a serious adverse event classified as related to CNT or the Backbeat Moderato device
Female subject who is pregnant, breast-feeding, intends to become pregnant or has the possibility of becoming pregnant during the conduct of the study and is not willing to use contraception during the study
Subject cannot or is unwilling to provide informed consent
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