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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Requirement of dual chamber pacemaker or upgrade from a single chamber to a dual chamber pacemaker.
* Stable (at least 6 weeks) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained without changes. Stable is defined as being in the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks.
* Average 24-hour ambulatory systolic blood pressure ≥ 130 mmHg (with directly observed medical therapy, DOT) and office blood pressure ≥140 mmHg.
* Subject is able to comply with study visits for at least 13 months (e.g., is capable and willing to travel to/from the center for all scheduled study visits).
Exclusion Criteria:
* Known secondary cause of HTN.
* 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 un…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of composite of major cardiac events
Timeframe: 12 months post Randomization
2
Change in average 24 hour systolic ambulatory blood pressure
Timeframe: Week 3 pre Randomization and 3 months post Randomization