Clinical Trials Logo

Clinical Trial 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.


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Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.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


Related Conditions & MeSH terms


NCT number NCT02909868
Study type Interventional
Source BackBeat Medical Inc
Contact Yuval Mika, Ph.D.
Phone +1856912155
Email ymika@backbeatmedical.com
Status Recruiting
Phase N/A
Start date September 2016
Completion date September 2018

See also
  Status Clinical Trial Phase
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Recruiting NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT03266510 - Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function N/A
Recruiting NCT02796313 - Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities N/A
Completed NCT00508365 - Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT03249753 - The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects Phase 1
Completed NCT03100812 - Asian American Partnerships in Research and Empowerment (AsPIRE) N/A
Recruiting NCT03288142 - The Smart Hypertension Control Study N/A
Recruiting NCT03099343 - Tailored Messaging to Reduce Sodium Intake N/A
Completed NCT02147626 - Heart Health 4 Moms N/A
Not yet recruiting NCT03293147 - OUTREACH: Urine Analysis and Antihypertensive Treatment N/A
Not yet recruiting NCT01620788 - Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment Phase 3
Not yet recruiting NCT03292393 - Social Norms and Antihypertensive Medication Adherence N/A
Recruiting NCT02299414 - Chronic Hypertension and Pregnancy (CHAP) Project Phase 4
Recruiting NCT02835287 - Diabetes Complication Control in Community Clinics (D4C) Trial N/A
Recruiting NCT02913664 - Risk Reduction for Alzheimer's Disease Phase 2/Phase 3
Recruiting NCT02919033 - Compare the Effects of Telemedicine Approach With Usual Care in Hypertension Management in China N/A
Active, not recruiting NCT02694432 - Minding GOALS: An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control N/A
Not yet recruiting NCT02894723 - L-arginine Treatment in Mild Hypertension Phase 4