RecruitingNot ApplicableNCT05719454

Novel Setup Algorithm for Cardiac Neuromodulation Therapy

Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals

Sponsor

BackBeat Medical Inc

Enrollment

30 participants

Start Date

Jun 21, 2023

Study Type

INTERVENTIONAL

Conditions

Hypertension Bradycardia

Summary

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

Min Age: 18 Years

Inclusion Criteria7

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
At 4 weeks from device implant, subject has an average 24-Hour ambulatory systolic blood pressure (aSBP) ≥130 mmHg and \<170 mmHg and an office blood pressure (oSBP) ≥140 and \<180 mmHg.
Subject is willing and able to comply with study visits and procedures
Subject is willing to adhere to the prescribed baseline antihypertension medical regimen for the duration of the study.

Exclusion Criteria21

\. 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%
Subject has a drop of \> 15% (absolute) in ejection fraction from baseline to week 4
Subject has symptoms of heart failure, NYHA Class II or greater
Subject has mitral regurgitation ≥2+, aortic stenosis with valve area \<1.0 cm2 , or is expected to need a valve repair or replacement.
Subject has a history of stroke or TIA within 12 months or any prior stroke with a residual neurological deficit (modified Rankin Score \>2+)
Subject experienced myocardial infarction (MI) within 3 months prior to enrolment
Subject had a cardiovascular interventional procedure or cardiovascular surgery within 6 months prior to enrolment
Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
Subject is on dialysis
Subject has estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m²
Subject has significant (\>50% occlusion of left or right carotid artery) carotid artery stenosis
Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden cardiac arrest
Subject has an active device-based treatment for hypertension
Subject has an existing active cardiac device or neurostimulator (e.g., ICD, spinal cord stimulator)
Subject has Type I Diabetes
Subject is a member of a vulnerable population (e.g., prisoners, pregnant or lactating women, mentally disabled)
Subject has the possibility of becoming pregnant during the conduct of the study and is not willing to use a means of contraception during the study
Subject cannot or is unwilling to provide informed consent