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Moderato System: A Double-Blind Randomized Trial Ver 1.1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837445
Recruitment Status : Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
MLM Medical Labs GmbH
nabios GmbH
Information provided by (Responsible Party):
BackBeat Medical Inc

Study Description
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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.

The primary objectives of this study are to provide evidence of safety and clinical efficacy of the anti-hypertensive effects of the Moderato System. This will be accomplished by evaluating changes in blood pressure in an active treatment vs. a control patient population for a period of 6 months.

The device will be considered to have a clinical effectiveness with regard to its anti-hypertension functions 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.


Condition or disease Intervention/treatment Phase
Hypertension Resistant to Conventional Therapy Bradycardia Atrioventricular Block Device: PHC ON Device: PHC OFF Not Applicable

Detailed Description:

Protocol CS-03 Ver 1.1 (NCT02837445) was amended at the advice of the Scientific Advisory to protocol CS-03 Version 3.0 with more stringent hypertension inclusion criteria and different observation intervals for efficacy and safety.

In CS-03 Version 3.0 the time of the primary efficacy endpoint was reduced from 6 months to 3 months post randomization which was deemed a suitable interval for the chronic effect, whereas for the safety endpoint, the period was lengthened from 6 month to 12 months post randomization to better monitor potential risks of the treatment on cardiac function (Blinding period was increased from 6 to 12 months). Protocols were thus split in order to allow better clarification to the difference in the time to the primary endpoints for efficacy and safety between the two CIP versions and simplify data analysis.

Protocol Ver 3.0 prescribes data analysis of all patients randomized under version 1.1 to be performed once they complete the 6 months follow-up as set in protocol version 1.1 (NCT0283744). It is expected that ~40 patients will be randomized according to protocol version 1.1 prior to the enrollment of patients according to protocol version 3.0. The results will be considered as interim analysis.

The recruitment for the protocol version 1.1 is now completed. Total of 47 patients were randomized according to protocol version 1.1 and all patients completed the follow-up period for the primary endpoint.

Patients are currently being followed up for the study "extension period".

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment
Eligible patients randomized after optimization phase to PHC ON for 6 months Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
 Device: PHC ON
Eligible patients randomized after optimization phase to PHC ON for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Placebo Comparator: Control
Eligible patients randomized after optimization phase to pacemaker only (PHC OFF) for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
 Device: PHC OFF
Eligible patients randomized after optimization phase to PHC OFF for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of composite of major cardiac events [ Time Frame: 6 months post Randomization ]
    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

  2. Change in average 24 hour systolic ambulatory blood pressure [ Time Frame: Week 3 pre Randomization and 6 months post Randomization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject requires an implant or replacement a of dual chamber pacemaker
  • Stable (at least one month) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained for 7 months.
  • Average day time (7AM-10PM) ambulatory systolic blood pressure ≥ 130 mmHg and office blood pressure ≥140 mmHg.
  • Subject lives in the proximity of the study center, which permits compliance with study visits for at least 7 months.

Exclusion Criteria:

  • 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 sudden death.
  • Previous active device-based treatment for HTN.
  • Existing implant, other than a pacemaker that needs replacing.
  • Subject is or has the possibility of becoming pregnant and is unwilling of contraception during the study.
  • Subject is unwilling or cannot provide Informed Consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837445


Locations
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Austria
Krankenhaus der Elisabethinen
Linz, Austria, 4020
Medical University Vienna
Vienna, Austria, 1090
Belgium
UZ Brussel - Heart Rhythm Management Center
Brussels, Belgium, 1090
Czechia
Na Homolce Hospital
Prague, Czechia, 15030
Hungary
Semmelweis University Heart and Vascular Center
Budapest, Hungary, 1122
Latvia
P. Stradins Clinical University Hospital
Riga, Latvia, 1002
Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, 08661
Poland
Medical University of Gdansk
Gdańsk, Poland, 80-952
Szpital Kliniczny Przemiemienia Panskiego
Poznań, Poland, 61-848
Pomeranian Medical University Hospital no. 2
Szczecin, Poland, 70-111
Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Warsaw, Poland, 02-097
Silesian Center for Heart Diseases
Zabrze, Poland, 41-800
Sponsors and Collaborators
BackBeat Medical Inc
Massachusetts General Hospital
MLM Medical Labs GmbH
nabios GmbH
Investigators
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Principal Investigator: Karl-Heinz Kuck, Prof. MD Asklepios Klinik St. Georg
More Information
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Responsible Party: BackBeat Medical Inc
ClinicalTrials.gov Identifier: NCT02837445    
Other Study ID Numbers: CS-03 Ver 1.1
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Hypertension
Bradycardia
Atrioventricular Block
Vascular Diseases
Cardiovascular Diseases
 Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Heart Block
Cardiac Conduction System Disease