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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| MLM Medical Labs GmbH | INDUSTRY |
| nabios GmbH | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Kuck, Prof. | Asklepios Klinik St. Georg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Elisabethinen | Linz | 4020 | Austria | |||
| Medical University Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29275370 | Background | 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. |
| Label | URL |
|---|---|
| Article describing study results | View source |
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| ID | Term |
|---|---|
| C563514 | Hypertension Resistant to Conventional Therapy |
| D001919 | Bradycardia |
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Vienna |
| 1090 |
| Austria |
| Clinica Tabancura | Santiago | Chile |
| Hospital Dr. Sotero del Rio | Santiago | Chile |
| Na Homolce Hospital | Prague | Czechia |
| Semmelweis University Heart and Vascular Center | Budapest | 1122 | Hungary |
| P. Stradins Clinical University Hospital | Riga | 1002 | Latvia |
| Vilnius University Hospital Santariskiu Klinikos | Vilnius | 08661 | Lithuania |
| Academic Medical Center - University of Amsterdam | Amsterdam | 1100 | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 | Netherlands |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |