Clinical trial NCT02282033: Safety and Performance Study of the Moderato System
Official title: Clinical Evaluation of Safety and Performance of the BackBeat Moderato System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension Resistant to Conventional Therapy
Bradycardia
Atrioventricular Block
Lead sponsor: BackBeat Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: MLM Medical Labs GmbH
name: nabios GmbH
First posted: 2014-11-04
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
timeFrame: 4 months
measure: Moderato Pacing Safety as measured by incidence of of peri-procedural device and treatment-related serious adverse events.
timeFrame: 4 months
measure: Hypertension Treatment Phase Performance as evaluated through analysis of 24 hour Holter monitoring recordings and 24h ambulatory blood pressure.
timeFrame: 3 months
measure: Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen
city: Vienna
country: Austria
facility: Medical University Vienna
city: Santiago
country: Chile
facility: Clinica Tabancura
city: Santiago
country: Chile
facility: Hospital Dr. Sotero del Rio
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
city: Amsterdam
country: Netherlands
facility: Academic Medical Center - University of Amsterdam
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Asklepios Klinik St. Georg
name: Karl-Heinz Kuck, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.