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

2016-09-21 20:23:22 | BioPortfolio


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.


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Following the completion of these measurements, the conductance catheter will be withdrawn and the Moderato System implant will resume as described in the CS-03 protocol.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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science






Na Homolce Hospital
Czech Republic




BackBeat Medical Inc

Results (where available)

View Results


Published on BioPortfolio: 2016-09-21T20:23:22-0400

Clinical Trials [788 Associated Clinical Trials listed on BioPortfolio]

Moderato System: A Double-Blind Randomized Trial

The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato pacemaker is indicated for patients who require a dual c...

Angiogenesis Inhibitors and Hypertension: Clinical Aspects

The aim of the study is to find simple clinical and laboratory parameters to predict the development of hypertension and to elucidate the mechanism of hypertension during treatment with th...

Improving Practice Patterns for the Treatment of Hypertension

To improve the quality of hypertension care in our facility, while concurrently, examining the relative contribution of each aspect of a multi-factorial intervention designed to improve hy...

Helius in Hypertension-I: The UK Hypertension Registry

The purpose of this study is to demonstrate the use of a digital health offering in the management of persistent hypertension during chronic anti-hypertensive treatment.

Study of Optimal Treatment Plan in Hypertensives With Anti-AT1-Receptor Autoantibody

The autoantibodies against AT1 receptor (ATR-AA), behaving like an agonist were detected in patients with hypertension. ATR-AA which can blocked by ARB may play a role in the pathogenesis ...

PubMed Articles [2288 Associated PubMed Articles listed on BioPortfolio]

The Role of Hyperglycemia and Insulin Resistance in the Development and Progression of Pulmonary Arterial Hypertension.

Pulmonary hypertension is a progressive disorder which often leads to right ventricular failure and death. While the existing classification system for pulmonary hypertension does not account for the ...

Linking inflammation and hypertension via LNK/SH2B3.

Hypertension is a leading cause of cardiovascular and renal morbidity, and mortality. Genome-wide association studies identified a single-nucleotide polymorphism in the gene SH2B3 encoding the lymphoc...


Masked hypertension is office normotension in the presence of ambulatory hypertension, which can be subdivided into isolated daytime, isolated nighttime or day-night hypertension. Up to now, no previo...

Prevalence, Awareness, Treatment, and Control of Hypertension in the Southern Cone of Latin America.

Hypertension is the leading global preventable risk factor for premature death. While hypertension prevalence has been declining in high-income countries, it has increased continuously in low- and mid...

Multivitamin use and the risk of hypertension in a prospective cohort study of women.

Despite the widespread use of multivitamin supplements, little is known regarding their effects on blood pressure (BP) and the development of hypertension. We, therefore, sought to prospectively inves...

Medical and Biotech [MESH] Definitions

A condition in pregnant women with elevated systolic (>140 mm Hg) and diastolic (>90 mm Hg) blood pressure on at least two occasions 6 h apart. HYPERTENSION complicates 8-10% of all pregnancies, generally after 20 weeks of gestation. Gestational hypertension can be divided into several broad categories according to the complexity and associated symptoms, such as EDEMA; PROTEINURIA; SEIZURES; abnormalities in BLOOD COAGULATION and liver functions.

Hypertension due to RENAL ARTERY OBSTRUCTION or compression.

Increased pressure within the cranial vault. This may result from several conditions, including HYDROCEPHALUS; BRAIN EDEMA; intracranial masses; severe systemic HYPERTENSION; PSEUDOTUMOR CEREBRI; and other disorders.

A condition of markedly elevated BLOOD PRESSURE with DIASTOLIC PRESSURE usually greater than 120 mm Hg. Malignant hypertension is characterized by widespread vascular damage, PAPILLEDEMA, retinopathy, HYPERTENSIVE ENCEPHALOPATHY, and renal dysfunction.

A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation. It is biosynthesized enzymatically from PROSTAGLANDIN ENDOPEROXIDES in human vascular tissue. The sodium salt has been also used to treat primary pulmonary hypertension (HYPERTENSION, PULMONARY).

More From BioPortfolio on "CS-03 Pressure-Volume Loop Sub-study With RV Lead Positioning"

Quick Search

Relevant Topics

Adempas (riociguat)
The United States Food and Drug Administration (FDA) has approved on October 8th 2013 Adempas® (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO* Group 4) after ...

Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of affected individuals. Symptoms can range from mild breathles...

Searches Linking to this Trial