Safety and Performance Study of the Moderato System

Not Applicable

Completed

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

• Registration Number: NCT02282033
• Lead Sponsor: BackBeat Medical Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Primary Completion: 2015-11
• Study Completion: 2017-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings	4 months
Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment	3 months
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.
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.

Trial Locations

Locations (10)

Krankenhaus der Elisabethinen; 🇦🇹 Linz, Austria

Medical University Vienna; 🇦🇹 Vienna, Austria

Clinica Tabancura; 🇨🇱 Santiago, Chile

Hospital Dr. Sotero del Rio; 🇨🇱 Santiago, Chile

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary

P. Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Vilnius University Hospital Santariskiu Klinikos; 🇱🇹 Vilnius, Lithuania

Academic Medical Center - University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands