Status:
COMPLETED
Safety and Performance Study of the Moderato System
Lead Sponsor:
BackBeat Medical Inc
Collaborating Sponsors:
Massachusetts General Hospital
MLM Medical Labs GmbH
Conditions:
Hypertension Resistant to Conventional Therapy
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hyper...
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years of age
- Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
- Subject has stable regimen of 2 or more maximally tolerated anti-hypertension medications, which is anticipated to be able to be maintained without changes for 3 months.
- Subject has office systolic blood pressure measurements \> 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is ≥150 mmHg
Exclusion
- Subject has known secondary cause of HTN
- Subject has a history of atrial fibrillation
- Subject has ejection fraction \<50%
- Subject has symptoms of heart failure of NYHA Class II or more
- Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
- Subject is on dialysis
- Subject has estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2
- Subject has prior neurological events (stroke or TIA) or carotid artery disease
- Subject has known autonomic dysfunction
- Subject has a history of clinically significant tachyarrhythmia
- Subject has had previous active device-based treatment for hypertension
- Subject has an existing implant, other than a pacemaker that needs replacing
- Subject with average Systolic BP \>190 mmHg
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02282033
Start Date
March 1 2013
End Date
August 1 2017
Last Update
February 22 2018
Active Locations (10)
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1
Krankenhaus der Elisabethinen
Linz, Austria, 4020
2
Medical University Vienna
Vienna, Austria, 1090
3
Clinica Tabancura
Santiago, Chile
4
Hospital Dr. Sotero del Rio
Santiago, Chile