An interventional study of BackBeat-PHC in Hypertension, sponsored by BackBeat Medical Inc. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by BackBeat Medical Inc · Not applicable, Interventional, and Basic science
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.
Subjects found eligible for participation in the CS-03 study, who are indicated for a de novo pulse generator implant at the center participating in this sub-study and who are not 100% dependent on RV pacing are eligible for participation in this sub-study.
Patients receiving a pacemaker pulse generator exchange or who are 100% pacemaker dependent may not participate.
Eligible patients will be provided with an Informed Consent specific to this sub-study and if patients choose to participate, patients will be asked to sign the Informed Consent and will then undergo the procedures described below.
Patients will be prepared and draped for the Moderato implant procedure as detailed in the main CS-03 study protocol.
Subjects will be instrumented prior to the Moderato Pacemaker implant procedure.
The position of the RV lead will be tested at two sites known to elicit shortest QRS duration (The RV apical septum and the His region).
A series of three test periods with the Moderato System programmed to deliver predetermined PHC settings will follow.
Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 5 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →BackBeat Medical Inc is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF
Device: BackBeat-PHC
A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.
Change in the LV volumes (ml)
LV volume will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
Time frame: up to 2 hr
Change in the LV pressures (mmHg)
LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
Time frame: up to 2 hr
Change in the pressure-volume ratio
LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
Time frame: up to 2 hr
Plan to share: Undecided
Ran from Sep 2016 to primary completion in May 2021, 55 months.
Of 95 industry-sponsored interventional studies with no phase under Hypertension, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's 55 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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BackBeat Medical Inc