Moderato-A Double-Blind Randomized Trial
Research type
Research Study
Full title
Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients with Hypertension: A Double-Blind Randomized Trial.
IRAS ID
202960
Contact name
Aldo Rinaldi
Contact email
Sponsor organisation
BackBeat Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
The study is a clinical evaluation of the BackBeat Moderato System, designed to treat patients with high blood pressure (hypertension) who also require a dual chamber cardiac pacemaker.
The study is a randomised, double-blind clinical trial in which 50% of the patients will receive active treatment with the Moderato System delivering hypertension therapy (in addition to the pacing function), and 50% of the patients will receive the Moderato System in pacemaker only mode.
Up to 170 patients from across the EU will be invited to participate in the randomised portion of the study, which will assess the safety and clinical efficacy of the Moderato System's hypertension therapy mode.
It is expected that up to 5 NHS Hospitals in the UK will participate and that patient recruitment will be complete within 2 years.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1732
Date of REC Opinion
25 Nov 2016
REC opinion
Further Information Favourable Opinion