NCT02282033

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
7 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

October 23, 2014

Last Update Submit

February 20, 2018

Conditions

Hypertension Resistant to Conventional TherapyBradycardiaAtrioventricular Block

Outcome Measures

Primary Outcomes (4)

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

    4 months

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

    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.

    4 months

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

    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.

    3 months

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

    3 months

Study Arms (1)

Treatment

EXPERIMENTAL

This is an unblinded, treatment only study in which each patient serves as his or her own control. All patients who meet entry criteria will undergo implantation of the Moderato System. During the first month the pacemaker Performance will be evaluated and an additional 3 month period of treatment for studying the Moderato-HTN therapy effect.

Device: The Moderato System

Interventions

The Moderato SystemDEVICE

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.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Krankenhaus der Elisabethinen

Linz, 4020, Austria

Location

Medical University Vienna

Vienna, 1090, Austria

Location

Clinica Tabancura

Santiago, Chile

Location

Hospital Dr. Sotero del Rio

Santiago, Chile

Location

Na Homolce Hospital

Prague, Czechia

Location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

P. Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania

Location

Academic Medical Center - University of Amsterdam

Amsterdam, 1100, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584, Netherlands

Location

Related Publications (1)

  • Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974.

    PMID: 29275370BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension Resistant to Conventional TherapyBradycardiaAtrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Study Officials

  • Karl-Heinz Kuck, Prof.

    Asklepios Klinik St. Georg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 4, 2014

Study Start

March 1, 2013

Primary Completion

November 1, 2015

Study Completion

August 1, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

AU(2)LI(1)NL(2)LA(1)HU(1)CZ(1)CL(2)