Moderato System: A Double-Blind Randomized Trial Ver 1.1
NCT ID: NCT02837445
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
170 participants
INTERVENTIONAL
2016-07-12
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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".
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stable (at least one month) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained for 7 months.
* Average day time (7AM-10PM) ambulatory systolic blood pressure ≥ 130 mmHg and office blood pressure ≥140 mmHg.
* Subject lives in the proximity of the study center, which permits compliance with study visits for at least 7 months.
Exclusion Criteria
* Average ambulatory or office systolic BP \> 195 mmHg.
* Permanent atrial fibrillation.
* History of significant paroxysmal atrial fibrillation/flutter burden (defined as \>25% of beats).
* Cardiac ejection fraction \<50%.
* Symptoms of heart failure, NYHA Class II or greater.
* Hypertrophic cardiomyopathy, restrictive cardiomyopathy or inter-ventricular septal thickness ≥ 15 mm.
* Subject is on dialysis.
* Subject has an estimated Glomerular Filtration Rate \< 30 ml/min/1.73 m²
* Prior neurological events (stroke or TIA) within the past year or events at a prior time that has resulted in residual neurologic deficit.
* Carotid artery disease.
* Known autonomic dysfunction.
* History of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden death.
* Previous active device-based treatment for HTN.
* Existing implant, other than a pacemaker that needs replacing.
* Subject is or has the possibility of becoming pregnant and is unwilling of contraception during the study.
* Subject is unwilling or cannot provide Informed Consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
MLM Medical Labs GmbH
INDUSTRY
nabios GmbH
UNKNOWN
BackBeat Medical Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karl-Heinz Kuck, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Asklepios Klinik St. Georg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Krankenhaus der Elisabethinen
Linz, , Austria
Medical University Vienna
Vienna, , Austria
UZ Brussel - Heart Rhythm Management Center
Brussels, , Belgium
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
Medical University of Gdansk
Gdansk, , Poland
Szpital Kliniczny Przemiemienia Panskiego
Poznan, , Poland
Pomeranian Medical University Hospital no. 2
Szczecin, , Poland
Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Warsaw, , Poland
Silesian Center for Heart Diseases
Zabrze, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chovanec M, Merkely B, Sokal A, Petru J, Kralovec S, Drtina T, Mudroch M, Geller L, Osztheimer I, Morawski S, Mika YH, Fischer A, Evans SJ, Aviv R, Rosenthal N, Burkhoff D, Kuck KH, Neuzil P. Pressure-Volume Analysis Demonstrates Short- and Long-Term Hemodynamic Effects of Atrioventricular Interval Modulation Therapy in Hypertension. JACC Clin Electrophysiol. 2025 Jul 22:S2405-500X(25)00518-3. doi: 10.1016/j.jacep.2025.06.017. Online ahead of print.
Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CS-03 Ver 1.1
Identifier Type: -
Identifier Source: org_study_id