Moderato System: A Double-Blind Randomized Trial Ver 1.1
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|ClinicalTrials.gov Identifier: NCT02837445|
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : January 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Resistant to Conventional Therapy Bradycardia Atrioventricular Block||Device: PHC ON Device: PHC OFF||Not Applicable|
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.
The recruitment for the protocol version 1.1 is now completed. Total of 47 patients were randomized according to protocol version 1.1 and all patients completed the follow-up period for the primary endpoint.
Patients are currently being followed up for the study "extension period".
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial|
|Actual Study Start Date :||July 12, 2016|
|Actual Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Treatment
Eligible patients randomized after optimization phase to PHC ON for 6 months Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Device: PHC ON
Eligible patients randomized after optimization phase to PHC ON for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Placebo Comparator: Control
Eligible patients randomized after optimization phase to pacemaker only (PHC OFF) for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Device: PHC OFF
Eligible patients randomized after optimization phase to PHC OFF for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
- Rate of composite of major cardiac events [ Time Frame: 6 months post Randomization ]including heart failure, clinically significant arrhythmias eg, persistent or increased atrial fibrillation, serious ventricular arrhythmias, myocardial infarction, stroke, heart failure, renal failure and/or related safety events that result in death
- Change in average 24 hour systolic ambulatory blood pressure [ Time Frame: Week 3 pre Randomization and 6 months post Randomization ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837445
|Krankenhaus der Elisabethinen|
|Linz, Austria, 4020|
|Medical University Vienna|
|Vienna, Austria, 1090|
|UZ Brussel - Heart Rhythm Management Center|
|Brussels, Belgium, 1090|
|Na Homolce Hospital|
|Prague, Czechia, 15030|
|Semmelweis University Heart and Vascular Center|
|Budapest, Hungary, 1122|
|P. Stradins Clinical University Hospital|
|Riga, Latvia, 1002|
|Vilnius University Hospital Santariskiu Klinikos|
|Vilnius, Lithuania, 08661|
|Medical University of Gdansk|
|Gdańsk, Poland, 80-952|
|Szpital Kliniczny Przemiemienia Panskiego|
|Poznań, Poland, 61-848|
|Pomeranian Medical University Hospital no. 2|
|Szczecin, Poland, 70-111|
|Samodzielnym Publicznym Centralnym Szpitalem Klinicznym|
|Warsaw, Poland, 02-097|
|Silesian Center for Heart Diseases|
|Zabrze, Poland, 41-800|
|Principal Investigator:||Karl-Heinz Kuck, Prof. MD||Asklepios Klinik St. Georg|