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. The primary objectives of this study are to provide evidence of safety and clinical efficacy of the anti-hypertensive effects of the Moderato System. This will be accomplished by evaluating changes in blood pressure in an active treatment vs. a control patient population for a period of 6 months. The device will be considered to have a clinical effectiveness with regard to its anti-hypertension functions 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.


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 from 6 month to 12 months post randomization to better monitor potential risks of the treatment on cardiac function (Blinding period was increased from 6 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. The recruitment for the protocol version 1.1 is now completed. Total of 47 patients were randomized according to protocol version 1.1 and all patients completed the follow-up period for the primary endpoint. Patients are currently being followed up for the study "extension period". ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02837445
Study type Interventional
Source BackBeat Medical Inc
Contact
Status Active, not recruiting
Phase N/A
Start date July 12, 2016
Completion date March 2023

See also
  Status Clinical Trial Phase
Completed NCT03922386 - Safety and Electrical Performances of XFINE Leads N/A
Completed NCT03294018 - Heart Rate Changes Following the Administration of Sugammadex
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT05440071 - PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Completed NCT02153242 - The Effects of Selective Site Right Ventricular Pacing
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00950287 - Detection of Neonatal Bradycardia N/A
Completed NCT00721136 - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation N/A
Completed NCT00286858 - Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Completed NCT00158925 - The EASYTRAK EPI Clinical Investigation Phase 3
Completed NCT00180557 - Austria Study - Analysis of Difference Between Active and Passive Fixation Leads Phase 4
Completed NCT01076348 - Model 4965 Post-Approval Study
Completed NCT04198220 - BIO|STREAM.ICM Obesity
Recruiting NCT05298748 - The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants N/A
Recruiting NCT04353960 - The Alaska Oculocardiac Reflex Study
Terminated NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing N/A
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT05932602 - AVEIR DR Coverage With Evidence Development (CED) Study
Recruiting NCT05935007 - Aveir DR Real-World Evidence Post-Approval Study
Recruiting NCT04075084 - Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)