To evaluate the safety and effectiveness of the BackBeat Moderato system.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical Effectiveness
The primary efficacy endpoint of this study is difference of the mean change of
the
average 24-hour ambulatory systolic blood pressure (average at 3 months post
randomization visit *** average at pre-randomization Baseline visit) in the
active
treatment group (Group 1) compared to the mean change (average at 3 months post
randomization visit *** average at pre-randomization Baseline visit) in the
control group
(Group 2)
(Note: The Baseline pre-randomization 24-hour blood pressure is the mean
ambulatory
blood pressure measured at the 3 week visit during the Run-In Phase.)
Safety
The Moderato System will be considered safe if the rate of major adverse cardiac
events [including: heart failure, clinically significant arrhythmias (e.g.,
persistent or
increased atrial fibrillation, serious ventricular arrhythmias), myocardial
infarction,
stroke, heart failure and renal failure and/ or other related safety events
that result in
death] does not differ between groups through the 12 month randomized phase of
the
study..
Secondary outcome
Changes in the following parameters will be analyzed (in comparison to
pre-randomisation baseline values) and compared between groups using
descriptive statistics to provide additional information about the safety and
effectiveness of the therapy:
*
*-Average day-time blood pressures from 24-hour ambulatory monitoring after 3
months of therapy
*-Average night-time blood pressures from 24-hour ambulatory monitoring after 3
months of therapy
*-Office systolic and diastolic blood pressure measurements at each time point
*-Echocardiograms: Ejection fraction, left ventricular end-diastolic and
end-systolic volumes at each timepoint
*-Blood tests: ANP, BNP, Creatinine at each timepoint
*-Overall type and rate of adverse events through 12 months of observation
Background summary
Hypertension (HTN) ultimately affects 1 in 3 adults in most cultures and is one
of the most important factors contributing to cardiovascular morbidity and
mortality. Medications are usually effective in controlling blood pressure,
>40% of HTN patients remain with unacceptably high blood pressure.
Dual-chamber pacing is recommended for the management of symptomatic
bradycardia due to sick sinus syndrome, atrio-ventricular block, a combination
of these conditions or other situations in which patients are prone to
bradyarrhythmias. Currently available devices have evolved from simple
single-chamber, fixed-rate pacemakers to multichamber, rate-responsive units.
Pacemaker technology is well established, with well-defined hardware, firmware
and logic algorithms. The Backbeat Moderato system incorporates such
traditional pacing modes and algorithms to provide
pacing support to patients with all conditions currently indicated for dual
chamber pacing.
Study objective
To evaluate the safety and effectiveness of the BackBeat Moderato system.
Study design
A randomized, double-blind, multi-centric study in which patients are
randomized to either a cohort that will receive active treatment with the
Moderato System delivering hypertension therapy plus continued medical therapy
or to a cohort that will have the Moderato System in pacemaker only mode and
receive continued medical therapy.
Intervention
Standard implantation of a dual chamber pacemaker and the activation of the
BackBeat-PHC therapy.
Study burden and risks
Risks associated with Moderato IPG implant (risks to which the patient would be
exposed independent of participation in the study):
a. Arrhythmias, that can be serious in nature, including ventricular
tachycardia, ventricular fibrillation, atrial tachycardia, atrial fibrillation
b. Damage to the heart or heart muscle
c. Perforation of the atrium or ventricle
d. Acute or delayed pericardial tamponade
e. Myocardial infarction or ischemia
f. Punctured lung cavity (pneumothorax)
g. Bleeding possibly requiring a blood transfusion
h. Infection at the site of insertion of the device that may become a systemic
infection (sepsis)
i. Damage to the arteries or veins in the implant site
j. Pacemaker lead dislodgement
k. Pacemaker lead fracture
l. Loss of pacemaker sensing and/or capture that may lead to lightheadedness,
fatigue, syncope or death
m. Stroke or transient ischemic attack
n. Acute heart failure or cardiogenic shock
o. Development of chronic heart failure
p. Development of pacemaker syndrome
q. Erosion of the IPG device through the skin
r. Thrombosis of veins (including the superior vena cava)
s. Damage to the heart conduction system including right bundle branch block or
complete heart block
t. Fluid or blood (seroma or hematoma) collection around the pacemaker
u. Diaphragmatic and/or Phrenic Nerve stimulation
v. Pain and discomfort related to the implant that can last for several days
w. Side effects from medications used to alleviate pain and discomfort during
the implant procedure
x. Device malfunction that will require replacement of device
Complications from any of the above-mentioned risks may result in death.
Potential added risks associated with delivery of PHC therapy (anticipated
adverse device effects):
a. Device malfunction which may require device replacement or removal
b. Arrhythmias, including atrial fibrillation, atrial tachycardia or, less
likely, ventricular tachycardia or ventricular fibrillation
c. Myocardial infarction
d. Stroke or transient ischemic attack (TIA)
e. Development of heart failure and/or significant reduction of left
ventricular ejection fraction
f. Kidney dysfunction
g. Increase in heart rate due to activation of the neuro-hormonal system
h. Palpitations
i. Low blood pressure
j. Light headedness
k. Syncope
l. Development of unusual patient sensations, pain or discomfort
Since the Moderato-PHC therapy is experimental, there may be risks that are not
yet known.
Pregnant women or women who may become pregnant during the study may not
participate unless they are willing to use contraceptives for the duration of
the study. The physician will discuss this with the subject further. If the
subject does become pregnant during the study, the study physician should be
notified immediately.
There are no known risks associated with other examinations required for the
study (whether or not standard of care).
Risks which are generally associated with participating in a clinical study
a. The investigational treatment may have health risks as described above.
b. The study may require more time and attention than standard treatment. The
subject may need to visit the study site, take additional blood tests, stay in
the hospital more than the subject would if he/ she did not participate in the
study
c. It is possible that the subject will not benefit from the treatment.
d. Whether a new treatment will work cannot be known ahead of time. There is
always a chance that a new treatment may not work better than a standard
treatment, may not work at all, or may be harmful.
e. The treatment may cause side effects that are serious enough to require
medical attention.
BENEFITS
The blood pressure may decrease as a result of the Moderato PHC therapy. The
study will determine the degree to which this benefit can occur. In addition,
subjects will receive the Pacemaker treatment that they need. This study may
also improve or help to improve future treatment of persistent high blood
pressure
Union Square Drive 140
New Hope PA 18938
US
Union Square Drive 140
New Hope PA 18938
US
Listed location countries
Age
Inclusion criteria
1) Subject is * 18 years of age
2) Subject requires the implant or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker
3) Subject has stable (for prior 6 weeks) hypertension treatment with at least 1 antihypertensive drug, which is anticipated to be able to be maintained without changes .Stable is defined as being on the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks
4) Subject has an average 24 hour ambulatory systolic blood pressure of * 130mmHg (with directly observed medical therapy, DOT) and unattended automatic average and office systolic blood pressure *140 mmHg
5) Subject is able to comply with study visits for at least 13 months (e.g., is capable
and is willing to travel to/from the center for all scheduled study visits)..
Exclusion criteria
1) Subject has a known secondary cause of HTN
2) Subject with average ambulatory or office systolic BP >195 mmHg
3) Subject has permanent atrial fibrillation
4) Subject has a history of significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats). Fibrillation/flutter burden will be determined by pacemaker interrogation (for those already having a pre-existing pacemaker) or, otherwise, by patient history.
5) Subject has ejection fraction <50%
6) Subject has symptoms of heart failure, NYHA Class II or greater
7) Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness *15 mm
8) Subject is on dialysis
9) Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2
10) Subject has prior neurological events (stroke or TIA) within the past year or an event at any prior time that has resulted in residual neurologic deficit
11) Subject has a history of significant carotid artery disease (>50% occlusion of left or
right carotid artery)
12) Subject has a history of autonomic dysfunction
13) Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced cardiac arrest
14) Subject has had previous active device-based treatment for hypertension
15) Subject has an existing implant, other than a pacemaker that needs replacing
16) Subject is pregnant or has the possibility of becoming pregnant during the conduct of the study and is not willing to use a means of contraception during the study.
17) Subject cannot or is unwilling to provide informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02837445 |
| CCMO | NL56984.018.16 |