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Safety and Performance Study of the Moderato System

Primary Purpose

Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
The Moderato System
Sponsored by
BackBeat Medical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension Resistant to Conventional Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krankenhaus der Elisabethinen
  • Medical University Vienna
  • Clinica Tabancura
  • Hospital Dr. Sotero del Rio
  • Na Homolce Hospital
  • Semmelweis University Heart and Vascular Center
  • P. Stradins Clinical University Hospital
  • Vilnius University Hospital Santariskiu Klinikos
  • Academic Medical Center - University of Amsterdam
  • University Medical Center Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 23, 2014
Last Updated
February 20, 2018
Sponsor
BackBeat Medical Inc
Collaborators
Massachusetts General Hospital, MLM Medical Labs GmbH, nabios GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02282033
Brief Title
Safety and Performance Study of the Moderato System
Official Title
Clinical Evaluation of Safety and Performance of the BackBeat Moderato System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BackBeat Medical Inc
Collaborators
Massachusetts General Hospital, MLM Medical Labs GmbH, nabios GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The Moderato System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
Time Frame
4 months
Title
Moderato Pacing Safety as measured by incidence of of peri-procedural device and treatment-related serious adverse events.
Description
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.
Time Frame
4 months
Title
Hypertension Treatment Phase Performance as evaluated through analysis of 24 hour Holter monitoring recordings and 24h ambulatory blood pressure.
Description
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.
Time Frame
3 months
Title
Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, Prof.
Organizational Affiliation
Asklepios Klinik St. Georg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus der Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Clinica Tabancura
City
Santiago
Country
Chile
Facility Name
Hospital Dr. Sotero del Rio
City
Santiago
Country
Chile
Facility Name
Na Homolce Hospital
City
Prague
Country
Czechia
Facility Name
Semmelweis University Heart and Vascular Center
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
P. Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Academic Medical Center - University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1100
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29275370
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5779015/
Description
Article describing study results

Learn more about this trial

Safety and Performance Study of the Moderato System

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