Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05086523
Status:
RECRUITING
Last Update Posted:
2022-11-03
First Post:
2021-09-27
Brief Title:
Cardiac Neuromodulation Therapy CNT Washout Sub-Study
Sponsor:
BackBeat Medical Inc
Organization:
BackBeat Medical Inc
Study Overview
Official Title:
Addendum to Protocol CS-03 Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension A Double-Blind Randomized Trial NCT02837445
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 pressureset 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
One possible explanation for this observation is that the signal beneficially changes the pressureset 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None