Clinical Trials Logo

Clinical Trial Summary

The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a dual chamber pacemaker in order to reduce their blood pressure.

In this amended CS-03 protocol Version 3.0, the study will evaluate the safety and efficacy in a randomized, double-blind study following active treatment vs. a control patient population for a period of 3 month for efficacy and 12 months for safety (In comparison to 6 months for patients under protocol CS-03 Ver 1.1, NCT02837445).

The device will be considered to have a clinical effectiveness with regard to its anti-hypertension function if there is a statistically significant and clinically meaningful reduction in mean 24-hour ambulatory systolic blood pressure in the treatment group compared to the control group. The primary efficacy endpoint will be evaluated 3 months after randomization. The Primary safety analysis will compare the treatment and the control after 12 months of treatment.

Clinical Trial Description

Protocol CS-03 Ver 1.1 (NCT02837445) was amended at the advice of the Scientific Advisory to protocol CS-03 Version 3.0 with more stringent hypertension inclusion criteria and different observation intervals for efficacy and safety.

In CS-03 Version 3.0 the time of the primary efficacy endpoint was reduced from 6 months to 3 months post randomization which was deemed a suitable interval for the chronic effect, whereas for the safety endpoint, the period was lengthened to 12 months post randomization to better monitor potential risks of the treatment on cardiac function (Blinding period was increased from 6 months to 12 months). Protocols were thus split in order to allow better clarification to the difference in the time to the primary endpoints for efficacy and safety between the two CIP versions and simplify data analysis.

Protocol Ver 3.0 prescribes data analysis of all patients randomized under version 1.1 to be performed once they complete the 6 months follow-up as set in protocol version 1.1 (NCT0283744). It is expected that ~40 patients will be randomized according to protocol version 1.1 prior to the enrollment of patients according to protocol version 3.0. The results will be considered as interim analysis. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03757377
Study type Interventional
Source BackBeat Medical Inc
Contact Yuval Mika, Ph.D.
Phone +1856912155
Status Recruiting
Phase N/A
Start date August 30, 2017
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT02385864 - CPAP Effect on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension N/A
Completed NCT01833429 - Autonomic Dysfunction in Resistant Hypertension N/A
Completed NCT02426099 - Efficacy of Spironolactone in Cameroonian Diabetic Patients With Resistant Hypertension Phase 4
Not yet recruiting NCT03730519 - UK Registry for Baroreflex Activation Therapy N/A
Recruiting NCT02623036 - The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors Phase 1
Completed NCT02587533 - Peripheral Chemoreflex/Arterial Baroreflex Interaction in Patients With Electrical Carotid Sinus Stimulation N/A
Recruiting NCT01863082 - Resistant Hypertension and Physical Activity Performed in a Heated Pool N/A
Completed NCT01520506 - Rapid Renal Sympathetic Denervation for Resistant Hypertension N/A
Active, not recruiting NCT02369081 - Optimum Treatment for Drug-Resistant Hypertension Phase 4
Recruiting NCT02057783 - Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension N/A
Completed NCT01630928 - Renal Sympathetic Denervation and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors N/A
Completed NCT01848275 - Full Length Versus Proximal Renal Arteries Ablation N/A
Completed NCT01062763 - The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension Phase 3
Completed NCT01834118 - Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension N/A
Active, not recruiting NCT01703780 - The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis N/A
Not yet recruiting NCT02042066 - Safety and Efficacy Study of Extracorporeal Shockwave Therapy in the Treatment of Patients With Resistant Hypertension Phase 1
Completed NCT02667912 - Distal Renal Denervation N/A
Recruiting NCT00994617 - Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension Phase 4
Completed NCT01459042 - Prevalence of Primary Aldosteronism in Patients With Resistant Hypertension in China N/A
Recruiting NCT02128386 - Medication Adherence and "True" Resistance in Patients With Resistant Hypertension N/A