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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02282033 |
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Date of registration:
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23/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Performance Study of the Moderato System
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Scientific title:
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Clinical Evaluation of Safety and Performance of the BackBeat Moderato System |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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57 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02282033 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Chile
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Czech Republic
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Czechia
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Hungary
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Latvia
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Lithuania
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Netherlands
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Contacts
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Name:
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Karl-Heinz Kuck, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asklepios Klinik St. Georg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bradycardia
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Atrioventricular Block
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Hypertension Resistant to Conventional Therapy
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Intervention(s)
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Device: The Moderato System
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Primary Outcome(s)
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Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment
[Time Frame: 3 months]
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Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
[Time Frame: 4 months]
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Moderato Pacing Safety as measured by incidence of of peri-procedural device and treatment-related serious adverse events.
[Time Frame: 4 months]
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Hypertension Treatment Phase Performance as evaluated through analysis of 24 hour Holter monitoring recordings and 24h ambulatory blood pressure.
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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