CS-03 Pressure-Volume Loop Sub-study With RV Lead Positioning
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
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Sep 2016
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2016
CompletedStudy Start
First participant enrolled
September 15, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJanuary 10, 2023
January 1, 2023
4.9 years
September 13, 2016
January 9, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Change in the pressure-volume ratio
up to 2 hr
Study Arms (1)
RV location
EXPERIMENTALAll included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF
Interventions
A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.
Eligibility Criteria
You may qualify if:
- Subject was included in the CS-03 study
- Subject indicated for a de novo pulse generator implant
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Na Homolce Hospital
Prague, Czechia
Related 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.
PMID: 11738311BACKGROUNDKlotz 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.
PMID: 17853871BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Neuzil, Prof.
Na Homolce Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2016
First Posted
September 21, 2016
Study Start
September 15, 2016
Primary Completion
August 1, 2021
Study Completion
September 30, 2023
Last Updated
January 10, 2023
Record last verified: 2023-01