UnknownNot Applicable

Moderato System: A Double-Blind Randomized Trial Ver 1.1

Austria, Belgium, Czechia170 participantsStarted 2016-07-12

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject requires an implant or replacement a of dual chamber pacemaker * 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: * 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 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 unwil…

What they're measuring

Rate of composite of major cardiac events

Timeframe: 6 months post Randomization

Change in average 24 hour systolic ambulatory blood pressure

Timeframe: Week 3 pre Randomization and 6 months post Randomization

Trial details

NCT IDNCT02837445

SponsorBackBeat Medical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08