Safety and Performance Study of the Moderato System

BackBeat Medical

Status: Completed

Conditions: Bradycardia; Atrioventricular Block; Hypertension Resistant to Conventional Therapy

Treatments: Device: The Moderato System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02282033

CS-01

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Device: The Moderato System