Atrioventricular Block, Bradycardia, Hypertension Resistant to Conventional Therapy
Conditions
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.
Interventions
DEVICEThe Moderato System
The BackBeat Moderato System incorporates traditional pacing modes and algorithms to provide pacing support to patients with all conditions currently indicated for dual chamber pacing. In addition, a special pacing algorithm was developed to reduce blood pressure.
Sponsors
Massachusetts General Hospital
MLM Medical Labs GmbH
nabios GmbH
BackBeat Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Subject has had previous active device-based treatment for hypertension * Subject has an existing implant, other than a pacemaker that needs replacing * Subject with average Systolic BP \>190 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings | 4 months | — |
| Moderato Pacing Safety as measured by incidence of of peri-procedural device and treatment-related serious adverse events. | 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. |
| Hypertension Treatment Phase Performance as evaluated through analysis of 24 hour Holter monitoring recordings and 24h ambulatory blood pressure. | 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. |
| Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment | 3 months | — |
Countries
Austria, Chile, Czechia, Hungary, Latvia, Lithuania, Netherlands
Outcome results
None listed