Safety and Performance Study of the Moderato System

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Safety and Performance of the BackBeat Moderato System

Conditions
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Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block

Intervention / Treatment
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* Device: The Moderato System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>This is an unblinded, treatment only study in which each patient serves as his or her own control. All patients who meet entry criteria will undergo implantation of the Moderato System. During the first month the pacemaker Performance will be evaluated and an additional 3 month period of treatment for studying the Moderato-HTN therapy effect. | Device: The Moderato System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 4 months | 
| Hypertension Treatment Phase Performance as evaluated through analysis of 24 hour Holter monitoring recordings and 24h ambulatory blood pressure. | 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. | 3 months | 
| Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment |  | 3 months |