Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02909868
Status:
UNKNOWN
Last Update Posted:
2023-01-10
First Post:
2016-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CS-03 Pressure-Volume Loop Sub-study With RV Lead Positioning
Sponsor:
BackBeat Medical Inc
Organization:
Study Overview
Official 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
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: