Safety and Performance Study of the Moderato System

Clinical Evaluation of Safety and Performance of the BackBeat Moderato System

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.

Study Overview

• Status: Completed
• Conditions: Bradycardia; Atrioventricular Block; Hypertension Resistant to Conventional Therapy
• Intervention / Treatment: Device: The Moderato System

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • Krankenhaus der Elisabethinen
  • Vienna, Austria, 1090
    • Medical University Vienna
• Chile
  • Santiago, Chile
    • Hospital Dr. Sótero del Río
  • Santiago, Chile
    • Clinica Tabancura
• Czechia
  • Prague, Czechia
    • Na Homolce Hospital
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University Heart and Vascular Center
• Latvia
  • Riga, Latvia, 1002
    • P. Stradins Clinical University Hospital
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santariskiu Klinikos
• Netherlands
  • Amsterdam, Netherlands, 1100
    • Academic Medical Center - University of Amsterdam
  • Utrecht, Netherlands, 3584
    • University Medical Center Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BackBeat Medical Inc
• Collaborators: Massachusetts General Hospital; MLM Medical Labs GmbH; nabios GmbH
• Investigators: Principal Investigator: Karl-Heinz Kuck, Prof., Asklepios Klinik St. Georg

Publications and helpful links

General Publications

• Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974.

Helpful Links

• Article describing study results

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (ESTIMATE): November 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Bradycardia; Atrioventricular Block
• Other Study ID Numbers: CS-01