Safety and Performance Study of the Moderato System

Not Applicable

Completed

• Conditions: Bradycardia; Atrioventricular Block; Hypertension Resistant to Conventional Therapy
• Interventions: Device: The Moderato System

• 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

Arm && Interventions

Group	Intervention	Description
Treatment	The Moderato System	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.

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

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

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

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Vilnius University Hospital Santariskiu Klinikos; 🇱🇹 Vilnius, Lithuania

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

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

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands