Safety and Performance Study of the Moderato System

Bradycardia Clinical Trial

Official title:

Clinical Evaluation of Safety and Performance of the BackBeat Moderato System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282033
• Other study ID #: CS-01
• Status: Completed
• Phase: N/A
• First received: October 23, 2014
• Last updated: February 20, 2018
• Start date: March 2013
• Est. completion date: August 2017

Study information

• Verified date: February 2018
• Source: BackBeat Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Block
• Bradycardia
• Coronary Vasospasm
• Hypertension
• Hypertension Resistant to Conventional Therapy

Intervention

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.

Locations

Country	Name	City	State
Austria	Krankenhaus der Elisabethinen	Linz
Austria	Medical University Vienna	Vienna
Chile	Clinica Tabancura	Santiago
Chile	Hospital Dr. Sotero del Rio	Santiago
Czechia	Na Homolce Hospital	Prague
Hungary	Semmelweis University Heart and Vascular Center	Budapest
Latvia	P. Stradins Clinical University Hospital	Riga
Lithuania	Vilnius University Hospital Santariskiu Klinikos	Vilnius
Netherlands	Academic Medical Center - University of Amsterdam	Amsterdam
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
BackBeat Medical Inc	MGH Echo Core Lab, MLM Medical Labs GmbH, nabios GmbH

Countries where clinical trial is conducted

Austria,  Chile,  Czechia,  Hungary,  Latvia,  Lithuania,  Netherlands, 

References & Publications (1)

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, Gellér 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). pii: e006974. doi: 10.1161/JAHA.117.006974. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings		4 months
Primary	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
Primary	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
Primary	Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment		3 months

External Links

•   Article describing study results