Moderato System in Patients With Hypertension
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|ClinicalTrials.gov Identifier: NCT03757377|
Recruitment Status : Active, not recruiting
First Posted : November 28, 2018
Last Update Posted : September 17, 2019
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.
In this amended CS-03 protocol Version 3.0, the study will evaluate the safety and efficacy in a randomized, double-blind study following active treatment vs. a control patient population for a period of 3 month for efficacy and 12 months for safety (In comparison to 6 months for patients under protocol CS-03 Ver 1.1, NCT02837445).
The device will be considered to have a clinical effectiveness with regard to its anti-hypertension function 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. The primary efficacy endpoint will be evaluated 3 months after randomization. The Primary safety analysis will compare the treatment and the control after 12 months of treatment.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Resistant to Conventional Therapy Atrioventricular Block||Device: BackBeat Moderato System Device: BackBeat Moderato Sytsem||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 to 12 months post randomization to better monitor potential risks of the treatment on cardiac function (Blinding period was increased from 6 months 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 :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||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 :||August 30, 2017|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: BackBeat Moderato System (PHC ON)
Eligible patients randomized after optimization phase to PHC ON (PHC algorithm active) for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
Device: BackBeat Moderato System
Eligible patients randomized after optimization phase to PHC ON for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Placebo Comparator: BackBeat Moderato System (PHC OFF)
Eligible patients randomized after optimization phase to pacemaker only (PHC OFF or PHC algorithm not active) for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
Device: BackBeat Moderato Sytsem
Eligible patients randomized after optimization phase to PHC OFF for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
- Rate of composite of major cardiac events [ Time Frame: 12 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 3 months post Randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757377
|UZ Brussel - Heart Rhythm Management Center|
|Brussels, Belgium, 1090|
|Vilnius University Hospital Santariskiu Klinikos|
|Vilnius, Lithuania, 08661|
|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|