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

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 Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Device: BackBeat-PHC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RV location<br>All included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF | Device: BackBeat-PHC<br>* A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |