Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients with Hypertension: A Double-Blind Randomized Trial

Withdrawn

• Conditions: Hypertension; high blood pressure; 10007521; 10057166

• Registration Number: NL-OMON46157
• Lead Sponsor: BackBeat Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1) Subject is * 18 years of age
2) Subject requires the implant or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker
3) Subject has stable (for prior 6 weeks) hypertension treatment with at least 1 antihypertensive drug, which is anticipated to be able to be maintained without changes .Stable is defined as being on the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks
4) Subject has an average 24 hour ambulatory systolic blood pressure of * 130mmHg (with directly observed medical therapy, DOT) and unattended automatic average and office systolic blood pressure *140 mmHg
5) Subject is able to comply with study visits for at least 13 months (e.g., is capable
and is willing to travel to/from the center for all scheduled study visits)..

Exclusion Criteria

1) Subject has a known secondary cause of HTN
2) Subject with average ambulatory or office systolic BP >195 mmHg
3) Subject has permanent atrial fibrillation
4) Subject has a history of significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats). Fibrillation/flutter burden will be determined by pacemaker interrogation (for those already having a pre-existing pacemaker) or, otherwise, by patient history.
5) Subject has ejection fraction <50%
6) Subject has symptoms of heart failure, NYHA Class II or greater
7) Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness *15 mm
8) Subject is on dialysis
9) Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2
10) Subject has prior neurological events (stroke or TIA) within the past year or an event at any prior time that has resulted in residual neurologic deficit
11) Subject has a history of significant carotid artery disease (>50% occlusion of left or
right carotid artery)
12) Subject has a history of autonomic dysfunction
13) Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced cardiac arrest
14) Subject has had previous active device-based treatment for hypertension
15) Subject has an existing implant, other than a pacemaker that needs replacing
16) Subject is pregnant or 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.
17) Subject cannot or is unwilling to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified