|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
9 January 2023 |
|
Main ID: |
NCT02837445 |
|
Date of registration:
|
08/07/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Moderato System: A Double-Blind Randomized Trial Ver 1.1
|
|
Scientific title:
|
Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial |
|
Date of first enrolment:
|
July 12, 2016 |
|
Target sample size:
|
170 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02837445 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Austria
|
Belgium
|
Czech Republic
|
Czechia
|
Hungary
|
Latvia
|
Lithuania
|
Poland
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Karl-Heinz Kuck, Prof. MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Asklepios Klinik St. Georg |
| | |
|
Key inclusion & exclusion criteria
|
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 unwilling of
contraception during the study.
- Subject is unwilling or cannot provide Informed Consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Bradycardia
|
|
Hypertension Resistant to Conventional Therapy
|
|
Atrioventricular Block
|
|
Intervention(s)
|
|
Device: PHC OFF
|
|
Device: PHC ON
|
|
Primary Outcome(s)
|
|
Change in average 24 hour systolic ambulatory blood pressure
[Time Frame: Week 3 pre Randomization and 6 months post Randomization]
|
|
Rate of composite of major cardiac events
[Time Frame: 6 months post Randomization]
|
|
Secondary ID(s)
|
|
CS-03 Ver 1.1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|