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

Not Applicable

Active, not recruiting

• Conditions: Hypertension
• Interventions: Device: BackBeat-PHC

• Registration Number: NCT02909868
• Lead Sponsor: BackBeat Medical Inc

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.

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Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.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

• Study First Submitted: 2016-09-13
• Study Start: 2016-09-15
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Primary Completion: 2021-08-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-10
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RV location	BackBeat-PHC	All included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF

Primary Outcome Measures

Name	Time	Method
Change in the LV pressures (mmHg)	up to 2 hr	LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
Change in the LV volumes (ml)	up to 2 hr	LV volume will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF

Secondary Outcome Measures

Name	Time	Method
Change in the pressure-volume ratio	up to 2 hr	LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF

Trial Locations

Locations (1)

Na Homolce Hospital; 🇨🇿 Prague, Czechia