Moderato System in Patients With Hypertension

NCT03757377 | Unknown DMC

• 1 other identifier: CS-03 Ver 3.0
• Study Type: interventional
• Target: 203
• Locations: 3 countries
• Sites: 4

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. 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.

Conditions

Hypertension, Resistant to Conventional Therapy; Atrioventricular Block

Outcome Measures

Primary Outcomes (2)

• Rate of composite of major cardiac events

  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

  12 months post Randomization

• Change in average 24 hour systolic ambulatory blood pressure

  Week 3 pre Randomization and 3 months post Randomization

Study Arms (2)

BackBeat Moderato System (PHC ON)

ACTIVE COMPARATOR

Eligible patients randomized after optimization phase to PHC ON (PHC algorithm active) for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.

Device: BackBeat Moderato System

BackBeat Moderato System (PHC OFF)

PLACEBO COMPARATOR

Eligible patients randomized after optimization phase to pacemaker only (PHC OFF or PHC algorithm not active) for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.

Device: BackBeat Moderato Sytsem

Interventions

BackBeat Moderato System DEVICE

Eligible patients randomized after optimization phase to PHC ON for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator

BackBeat Moderato System (PHC ON)

BackBeat Moderato Sytsem DEVICE

Eligible patients randomized after optimization phase to PHC OFF for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.

BackBeat Moderato System (PHC OFF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requirement of dual chamber pacemaker or upgrade from a single chamber to a dual chamber pacemaker.
• Stable (at least 6 weeks) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained without changes. Stable is defined as being in the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks.
• Average 24-hour ambulatory systolic blood pressure ≥ 130 mmHg (with directly observed medical therapy, DOT) and office blood pressure ≥140 mmHg.
• Subject is able to comply with study visits for at least 13 months (e.g., is capable and willing to travel to/from the center for all scheduled study visits).

You may not qualify if:

• 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 cardiac arrest.
• Previous active device-based treatment for HTN.
• Existing implant, other than a pacemaker that needs replacing.

Sponsors & Collaborators

• BackBeat Medical Inc: lead
• Massachusetts General Hospital: collaborator
• MLM Medical Labs GmbH: collaborator
• nabios GmbH: collaborator

Study Sites (4)

UZ Brussel - Heart Rhythm Management Center

Brussels, 1090, Belgium

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania

Location

Samodzielnym Publicznym Centralnym Szpitalem Klinicznym

Warsaw, 02-097, Poland

Location

Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

Location

Related Links

• Rationale and evidence for the development of a durable device-based cardiac neuromodulation therapy for hypertension.
• Pacemaker-Mediated Programmable Hypertension Control Therapy.

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy; Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl-Heinz Kuck, Prof. MD

  Asklepios Klinik St. Georg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 28, 2018
• Study Start: August 30, 2017
• Primary Completion: February 1, 2021
• Study Completion: March 30, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

PL (2); BE (1); LI (1)