Clinical Evaluation of Safety and Performance of the BackBeat Moderato System
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hypertension Resistant to Conventional Therapy
- Sponsor
- BackBeat Medical Inc
- Enrollment
- 57
- Locations
- 10
- Primary Endpoint
- Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥ 18 years of age
- •Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
- •Subject has stable regimen of 2 or more maximally tolerated anti-hypertension medications, which is anticipated to be able to be maintained without changes for 3 months.
- •Subject has office systolic blood pressure measurements \> 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is ≥150 mmHg
Exclusion Criteria
- •Subject has known secondary cause of HTN
- •Subject has a history of atrial fibrillation
- •Subject has ejection fraction \<50%
- •Subject has symptoms of heart failure of NYHA Class II or more
- •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 prior neurological events (stroke or TIA) or carotid artery disease
- •Subject has known autonomic dysfunction
- •Subject has a history of clinically significant tachyarrhythmia
Outcomes
Primary Outcomes
Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
Time Frame: 4 months
Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment
Time Frame: 3 months
Hypertension Treatment Phase Performance as evaluated through analysis of 24 hour Holter monitoring recordings and 24h ambulatory blood pressure.
Time Frame: 3 months
Moderato - Hypertension device performance will be evaluated through analysis of 24 hour Holter monitoring recordings. The device will be considered to be efficacious if there is a reduction of average office blood pressure and/or a reduction in averaged mean 24-hour ambulatory blood pressure.
Moderato Pacing Safety as measured by incidence of of peri-procedural device and treatment-related serious adverse events.
Time Frame: 4 months
The pacemaker function of the system will be considered to be safe if the rate and severity of pacemaker-related complications is not greater than reported in the literature for similar devices.