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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
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.
Krankenhaus der Elisabethinen
Linz, Austria
Medical University Vienna
Vienna, Austria
Clinica Tabancura
Santiago, Chile
Hospital Dr. Sotero del Rio
Santiago, Chile
Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
Time frame: 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.
Time frame: 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.
Time frame: 3 months
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
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Na Homolce Hospital
Prague, Czechia
Semmelweis University Heart and Vascular Center
Budapest, Hungary
P. Stradins Clinical University Hospital
Riga, Latvia
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
Academic Medical Center - University of Amsterdam
Amsterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands