CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled / 5 target
Drug / intervention
BackBeat-PHCdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02909868
NCT02909868N/ACompletedUpdate Overdue (0.0/mo)Completion was 61mo ago
CompareCT.gov

Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial - PV Loops Sub-study

BackBeat Medical Inc·interventional·Posted Sep 21, 2016·Updated Jun 18, 2026

In Brief

A clinical study evaluating BackBeat-PHC for Hypertension. Completed, enrolled 5 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

The position of the RV lead may have an important role in the effectiveness of the Programmable Hypertension Control (PHC) therapy by the Moderato pacemaker eliciting a lag from which RV signals (QRS) are identified. The study attempts to measure RV Pressure and RV Volume with PHC in two RV lead locations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 21, 2016
Enrollment StartSep 15, 2016
Primary CompletionMay 13, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.8 years ago

Arms & Interventions

RV locationexperimental

All included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF

Device: BackBeat-PHC

Interventions

BackBeat-PHCdevice

A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.