Safety and Performance Study of the Moderato System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-08-31

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.

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Detailed Description

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Conditions

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Hypertension Resistant to Conventional Therapy Bradycardia Atrioventricular Block

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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.

Group Type EXPERIMENTAL

The Moderato System

Intervention Type DEVICE

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.

Interventions

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The 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No