Trials / Completed
CompletedNCT02282033
Safety and Performance Study of the Moderato System
Clinical Evaluation of Safety and Performance of the BackBeat Moderato System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- BackBeat Medical Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 hypertension, in order to reduce their blood pressure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | The Moderato System | The BackBeat Moderato System incorporates traditional pacing modes and algorithms to provide pacing support to patients with all conditions currently indicated for dual chamber pacing. In addition, a special pacing algorithm was developed to reduce blood pressure. |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2015-11-01
- Completion
- 2017-08-01
- First posted
- 2014-11-04
- Last updated
- 2018-02-22
Locations
10 sites across 7 countries: Austria, Chile, Czechia, Hungary, Latvia, Lithuania, Netherlands
Source: ClinicalTrials.gov record NCT02282033. Inclusion in this directory is not an endorsement.