Last updated on December 2018

Moderato System: A Double-Blind Randomized Trial Ver 1.1

Brief description of study

The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System.

The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a dual chamber pacemaker in order to reduce their blood pressure.

The primary objectives of this study are to provide evidence of safety and clinical efficacy of the anti-hypertensive effects of the Moderato System. This will be accomplished by evaluating changes in blood pressure in an active treatment vs. a control patient population for a period of 6 months.

The device will be considered to have a clinical effectiveness with regard to its anti-hypertension functions if there is a statistically significant and clinically meaningful reduction in mean 24-hour ambulatory systolic blood pressure in the treatment group compared to the control group.

Detailed Study Description

Protocol CS-03 Ver 1.1 (NCT02837445) was amended at the advice of the Scientific Advisory to protocol CS-03 Version 3.0 with more stringent hypertension inclusion criteria and different observation intervals for efficacy and safety.

In CS-03 Version 3.0 the time of the primary efficacy endpoint was reduced from 6 months to 3 months post randomization which was deemed a suitable interval for the chronic effect, whereas for the safety endpoint, the period was lengthened from 6 month to 12 months post randomization to better monitor potential risks of the treatment on cardiac function (Blinding period was increased from 6 to 12 months). Protocols were thus split in order to allow better clarification to the difference in the time to the primary endpoints for efficacy and safety between the two CIP versions and simplify data analysis.

Protocol Ver 3.0 prescribes data analysis of all patients randomized under version 1.1 to be performed once they complete the 6 months follow-up as set in protocol version 1.1 (NCT0283744). It is expected that ~40 patients will be randomized according to protocol version 1.1 prior to the enrollment of patients according to protocol version 3.0. The results will be considered as interim analysis.

Clinical Study Identifier: NCT02837445

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Josef Aichinger, Prim. Mag.

Krankenhaus der Elisabethinen
Linz, Austria
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Thomas Pezawas, Prof.

Medical University Vienna
Vienna, Austria
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Yuval Mika, Ph.D.

OLV Hospital Aalst
Aalst, Belgium
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Yuval Mika, Ph.D.

ZNA Middelheim
Antwerp, Belgium
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Carlo de Asmundis, Prof.

UZ Brussel - Heart Rhythm Management Center
Brussels, Belgium
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Petr Neuzil, Prof.

Na Homolce Hospital
Prague, Czechia
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Béla Merkely, Prof.

Semmelweis University Heart and Vascular Center
Budapest, Hungary
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Andrejs Erglis, Prof.

P. Stradins Clinical University Hospital
Riga, Latvia
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Yuval Mika, Ph.D.

Hospital of Lithuanian University of Health Science Kauno Klinikos
Kaunas, Lithuania
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Yuval Mika, Ph.D.

Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
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Zbigniew Kalarus, Prof.

Silesian Center for Heart Diseases
Zabrze, Poland
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John R Paisey, MD

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
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Shaumik Adhya, MD

Medway NHS Foundation Trust
Gillingham, United Kingdom
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Aldo Dr Rinaldi, MD

St Thomas Hospital
London, United Kingdom
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