HypertensionNCT02909868
CS-03 Pressure-Volume Loop Sub-study With RV Lead Positioning
A study testing BackBeat-PHC in people with Hypertension, run by BackBeat Medical Inc at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- BackBeat-PHC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Sep 2016to 13 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject was included in the CS-03 study
- Subject indicated for a de novo pulse generator implant
Who cannot join
- Subject was excluded from the CS-03 study
- Subject is not 100% dependent on RV pacing
- Subject receiving a pacemaker pulse generator exchange
- Subject is unwilling or cannot provide Informed Consent for this sub study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- BackBeat-PHC
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BackBeat-PHCDevice
A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.
| Study group | Role | What they receive |
|---|---|---|
| RV location | Experimental | All included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF Receives: Device: BackBeat-PHC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the LV volumes (ml)
LV volume will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
Measured: 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
Measured: up to 2 hr
Secondary outcomes (1)
Change in the pressure-volume ratio
LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
Measured: up to 2 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start15 Sep 2016
- Primary completion13 May 2021
- Study completion13 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, Prof., Principal investigator, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909868
- Sponsor's protocol ID
- CS-03 PV Loop substudy
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular end-systolic elastance in humans. J Am Coll Cardiol. 2001 Dec;38(7):2028-34. doi: 10.1016/s0735-1097(01)01651-5.
PubMed 11738311Klotz S, Dickstein ML, Burkhoff D. A computational method of prediction of the end-diastolic pressure-volume relationship by single beat. Nat Protoc. 2007;2(9):2152-8. doi: 10.1038/nprot.2007.270.
PubMed 17853871
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02909868
- Acronym / sponsor ID
- CS-03 PV Loop substudy
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BackBeat Medical IncIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RV location | Experimental | Device: BackBeat-PHCAll included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject was included in the CS-03 study
- Subject indicated for a de novo pulse generator implant
Key exclusion criteria (4 listed)
- Subject was excluded from the CS-03 study
- Subject is not 100% dependent on RV pacing
- Subject receiving a pacemaker pulse generator exchange
- Subject is unwilling or cannot provide Informed Consent for this sub study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BackBeat-PHCA conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure. | Device | RV location |
Primary outcome
Change in the LV volumes (ml)
Time frame: up to 2 hr
LV volume will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
Change in the LV pressures (mmHg)
Time frame: up to 2 hr
LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
1 secondary outcome
Change in the pressure-volume ratio
Time frame: up to 2 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 11738311Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular end-systolic elastance in humans. J Am Coll Cardiol. 2001 Dec;38(7):2028-34. doi: 10.1016/s0735-1097(01)01651-5.
- Background: PubMed 17853871Klotz S, Dickstein ML, Burkhoff D. A computational method of prediction of the end-diastolic pressure-volume relationship by single beat. Nat Protoc. 2007;2(9):2152-8. doi: 10.1038/nprot.2007.270.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Neuzil, Prof. principal investigator
Na Homolce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BackBeat-PHC in people with Hypertension, run by BackBeat Medical Inc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the LV volumes (ml) (time frame: up to 2 hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909868, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.