Status:
UNKNOWN
Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)
Lead Sponsor:
BackBeat Medical Inc
Collaborating Sponsors:
CD Leycom
Conditions:
Bradycardia
Hypertension, Systolic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This investigation will evaluate the effect of RV pacing lead position on cardiac function and the modulation of the autonomic nervous system with Cardiac Neuromodulation Therapy (CNT) pacing signals....
Detailed Description
Subjects indicated for a dual chamber pacemaker implant or replacement who are not 100% dependent on right ventricular pacing may be eligible to participate in the study. This investigation will eval...
Eligibility Criteria
Inclusion
- 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 known Hypertension
- Subject is willing and able to comply with the study and procedures.
Exclusion
- Subject has symptoms of heart failure, NYHA Class II or greater
- Subject has significant (\>2+) mitral regurgitation, aortic regurgitation or aortic stenosis.
- Subject has permanent atrial fibrillation
- Subject has atrial fibrillation on the day of the study.
- Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
- Subject is on dialysis
- Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke or TIA) at any prior time that has resulted in residual neurologic deficit.
- Subject has a history of autonomic dysfunction
- Women who are pregnant or breast-feeding
- Subject cannot or is unwilling to provide informed consent.
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04463121
Start Date
August 7 2020
End Date
July 31 2023
Last Update
September 19 2022
Active Locations (1)
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1
Na Homolce Hospital
Prague, Czechia, 15030