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Completed

NCT Number: NCT02909868

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Na Homolce Hospital

Prague, Czechia

About this study

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Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BackBeat-PHC

Device

A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.

Primary outcomes

  1. Change in the LV volumes (ml)

    Time frame: up to 2 hr

    LV volume will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF

  2. Change in the LV pressures (mmHg)

    Time frame: up to 2 hr

    LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF

Secondary outcomes

  1. Change in the pressure-volume ratio

    Time frame: up to 2 hr

    LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF

Sponsors and collaborators

Lead sponsor

BackBeat Medical Inc

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2016
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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