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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension
• Intervention / Treatment: Device: BackBeat-PHC

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Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Na Homolce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BackBeat Medical Inc
• Investigators: Principal Investigator: Petr Neuzil, Prof., Na Homolce Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2016
• Primary Completion (Actual): August 1, 2021
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CS-03 PV Loop substudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided