Status:
UNKNOWN
Moderato System in Patients With Hypertension
Lead Sponsor:
BackBeat Medical Inc
Collaborating Sponsors:
Massachusetts General Hospital
MLM Medical Labs GmbH
Conditions:
Hypertension, Resistant to Conventional Therapy
Atrioventricular Block
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 hyper...
Detailed Description
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 in...
Eligibility Criteria
Inclusion
- 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
- 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 cardiac arrest.
- 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
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT03757377
Start Date
August 30 2017
End Date
March 30 2023
Last Update
December 14 2022
Active Locations (4)
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1
UZ Brussel - Heart Rhythm Management Center
Brussels, Belgium, 1090
2
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, 08661
3
Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Warsaw, Poland, 02-097
4
Silesian Center for Heart Diseases
Zabrze, Poland, 41-800