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NCT02909868 Clinical Trial

CS-03 Pressure-Volume Loop Sub-study With RV Lead Positioning

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02909868
Other study ID # CS-03 PV Loop substudy
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 15, 2016
Est. completion date September 30, 2023

Study information
Verified date January 2023
Source BackBeat Medical Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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 Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date September 30, 2023
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject was included in the CS-03 study - Subject indicated for a de novo pulse generator implant Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• BackBeat-PHC
A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.

Locations
Country Name City State
Czechia Na Homolce Hospital Prague

Sponsors (1)
Lead Sponsor Collaborator
BackBeat Medical Inc

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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. — View Citation

Klotz 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the LV volumes (ml) LV volume will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF up to 2 hr
Primary Change in the LV pressures (mmHg) LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF up to 2 hr
Secondary Change in the pressure-volume ratio LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF up to 2 hr
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