Moderato System: A Double-Blind Randomized Trial Ver 1.1

Not Applicable

Active, not recruiting

• Conditions: Hypertension Resistant to Conventional Therapy; Atrioventricular Block; Bradycardia
• Interventions: Device: PHC ON; Device: PHC OFF

• Registration Number: NCT02837445
• Lead Sponsor: BackBeat Medical Inc

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2016-07-08
• Study Start: 2016-07-12
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-19
• Primary Completion: 2019-08
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Subject requires an implant or replacement a of dual chamber pacemaker
• Stable (at least one month) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained for 7 months.
• Average day time (7AM-10PM) ambulatory systolic blood pressure ≥ 130 mmHg and office blood pressure ≥140 mmHg.
• Subject lives in the proximity of the study center, which permits compliance with study visits for at least 7 months.

Exclusion Criteria

• Known secondary cause of HTN.
• Average ambulatory or office systolic BP > 195 mmHg.
• Permanent atrial fibrillation.
• History of significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats).
• Cardiac ejection fraction <50%.
• Symptoms of heart failure, NYHA Class II or greater.
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy or inter-ventricular septal thickness ≥ 15 mm.
• Subject is on dialysis.
• Subject has an estimated Glomerular Filtration Rate < 30 ml/min/1.73 m²
• Prior neurological events (stroke or TIA) within the past year or events at a prior time that has resulted in residual neurologic deficit.
• Carotid artery disease.
• Known autonomic dysfunction.
• History of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden death.
• Previous active device-based treatment for HTN.
• Existing implant, other than a pacemaker that needs replacing.
• Subject is or has the possibility of becoming pregnant and is unwilling of contraception during the study.
• Subject is unwilling or cannot provide Informed Consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	PHC ON	Eligible patients randomized after optimization phase to PHC ON for 6 months Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Control	PHC OFF	Eligible patients randomized after optimization phase to pacemaker only (PHC OFF) for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator

Primary Outcome Measures

Name	Time	Method
Rate of composite of major cardiac events	6 months post Randomization	including heart failure, clinically significant arrhythmias eg, persistent or increased atrial fibrillation, serious ventricular arrhythmias, myocardial infarction, stroke, heart failure, renal failure and/or related safety events that result in death
Change in average 24 hour systolic ambulatory blood pressure	Week 3 pre Randomization and 6 months post Randomization

Trial Locations

Locations (12)

Medical University Vienna; 🇦🇹 Vienna, Austria

Krankenhaus der Elisabethinen; 🇦🇹 Linz, Austria

UZ Brussel - Heart Rhythm Management Center; 🇧🇪 Brussels, Belgium

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Vilnius University Hospital Santariskiu Klinikos; 🇱🇹 Vilnius, Lithuania

Medical University of Gdansk; 🇵🇱 Gdańsk, Poland

Szpital Kliniczny Przemiemienia Panskiego; 🇵🇱 Poznań, Poland

Pomeranian Medical University Hospital no. 2; 🇵🇱 Szczecin, Poland

Samodzielnym Publicznym Centralnym Szpitalem Klinicznym; 🇵🇱 Warsaw, Poland

P. Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Silesian Center for Heart Diseases; 🇵🇱 Zabrze, Poland