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Completed

NCT Number: NCT02282033

Safety and Performance Study of the Moderato System

The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.

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Key information

Conditions

Hypertension Resistant to Conventional Therapy Arrhythmias, Cardiac Atrioventricular Block Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus der Elisabethinen, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is ≥ 18 years of age
  • Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
  • Subject has stable regimen of 2 or more maximally tolerated anti-hypertension medications, which is anticipated to be able to be maintained without changes for 3 months.
  • Subject has office systolic blood pressure measurements > 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is ≥150 mmHg

Exclusion criteria

  • Subject has known secondary cause of HTN
  • Subject has a history of atrial fibrillation
  • Subject has ejection fraction <50%
  • Subject has symptoms of heart failure of NYHA Class II or more
  • Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
  • Subject is on dialysis
  • Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2
  • Subject has prior neurological events (stroke or TIA) or carotid artery disease
  • Subject has known autonomic dysfunction
  • Subject has a history of clinically significant tachyarrhythmia
  • Subject has had previous active device-based treatment for hypertension
  • Subject has an existing implant, other than a pacemaker that needs replacing
  • Subject with average Systolic BP >190 mmHg

Treatment and study plan

The Moderato System

Device

The BackBeat Moderato System incorporates traditional pacing modes and algorithms to provide pacing support to patients with all conditions currently indicated for dual chamber pacing. In addition, a special pacing algorithm was developed to reduce blood pressure.

Primary outcomes

  1. Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings

    Time frame: 4 months

  2. Moderato Pacing Safety as measured by incidence of of peri-procedural device and treatment-related serious adverse events.

    Time frame: 4 months

    The pacemaker function of the system will be considered to be safe if the rate and severity of pacemaker-related complications is not greater than reported in the literature for similar devices.

  3. Hypertension Treatment Phase Performance as evaluated through analysis of 24 hour Holter monitoring recordings and 24h ambulatory blood pressure.

    Time frame: 3 months

    Moderato - Hypertension device performance will be evaluated through analysis of 24 hour Holter monitoring recordings.

    The device will be considered to be efficacious if there is a reduction of average office blood pressure and/or a reduction in averaged mean 24-hour ambulatory blood pressure.

  4. Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

BackBeat Medical Inc

Industry

Collaborators

  • MLM Medical Labs GmbH
  • Massachusetts General Hospital
  • nabios GmbH

Registry information

Official study title

Clinical Evaluation of Safety and Performance of the BackBeat Moderato System

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Nov 4, 2014
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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