Hypertension Resistant to Conventional TherapyNCT02282033
Safety and Performance Study of the Moderato System
A study testing The Moderato System in people with Hypertension Resistant to Conventional Therapy and Bradycardia, run by BackBeat Medical Inc at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- What is being tested?
- The Moderato System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 10 sitesin 7 countries
- Study dates
- Mar 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Austria2 sites
Krankenhaus der Elisabethinen
Linz, 4020
Medical University Vienna
Vienna, 1090
Netherlands2 sites
Academic Medical Center - University of Amsterdam
Amsterdam, 1100
University Medical Center Utrecht
Utrecht, 3584
Lithuania1 site
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661
About this study
Official title: Clinical Evaluation of Safety and Performance of the BackBeat 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.
- Being tested
- The Moderato System
- Medical subject headings
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Moderato System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
Measured: 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.
Measured: 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.
Measured: 3 months
Hypertension Treatment Phase Safety as measured by Incidence of device- and treatment-related serious adverse events through 3 months of treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension Resistant to Conventional TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, MLM Medical Labs GmbH, nabios GmbH
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Kuck, Prof., Principal investigator, Asklepios Klinik St. Georg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282033
- Sponsor's protocol ID
- CS-01
- Status last verified
- Feb 2018
- First submitted
- 23 Oct 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29275370
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Safety and Performance of the BackBeat Moderato System
- ClinicalTrials.gov ID
- NCT02282033
- Acronym / sponsor ID
- CS-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- BackBeat Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, MLM Medical Labs GmbH, nabios GmbH
- Study start
- Mar 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: The Moderato SystemThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Moderato SystemThe 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. | Device | Treatment |
Primary outcome
Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings
Time frame: 4 months
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Background: PubMed 29275370Neuzil 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.
- Article describing study resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Heinz Kuck, Prof. principal investigator
Asklepios Klinik St. Georg
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Moderato System in people with Hypertension Resistant to Conventional Therapy and Bradycardia, run by BackBeat Medical Inc at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Austria, Chile, Netherlands, Czechia, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderato Pacing Performance as evaluated through analysis of 24 hour Holter monitoring recordings (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02282033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.