To evaluate the safety and performance 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
A. Pacemaker phase
A.1. Primary performance endpoint
Moderato pacing performance will be evaluated through analysis of 24 hour
Holter monitoring recordings. Additionally, the pacemaker performance will be
evaluated by temporarily programming the IPG to different modes (including DDD,
VVI) with different rate and timing parameters to evaluate appropriate clinical
pacemaker performance.
A.2. Primary safety endpoint
Incidence of device- and treatment-related serious adverse events through the
peri-procedural and 3-month follow-up period.
B. Hypertension phase
B.1. Primary performance endpoint
Moderato - HTN device performance will be evaluated through analysis of 24 hour
Holter monitoring recordings.
B.2. Primary safety endpoint
Incidence of device- and treatment-related serious adverse events through 3
months of treatment.
Secondary outcome
In addition to the above noted endpoints, the additional endpoints listed below
will be measured. For each of these parameters, the baseline values determined
at the visit just prior to initiation of the Moderato-HTN therapy will be
compared to the final values determined at the 3 month visit. The one
exception to this is that the baseline echocardiogram will be the one obtained
during the original study screening period.
• Change in average diastolic blood pressure after 3 months of treatment
• Change in the daytime-nighttime difference in BP after 3 months of treatment
• Change in the average nighttime BP after 3 months of treatment
• Change in left ventricular ejection fraction (by echocardiography) after 3
months of treatment
• Changes in proteinuria after 3 months of treatment
• Incidence of the occurrence of *pacemaker syndrome*
• Changes in serum neurohormone levels (BNP)
• Incidence of device malfunction
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
brady-arrhythmias. Currently available devices have evolved from simple
single-chamber, fixed-rate pacemakers to multi-chamber, 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 performance of the BackBeat Moderato system.
Study design
Prospective, non-randomised, multi-centric study.
Intervention
Standard implantation of a dual chamber pacemaker and the activation of the
MOderato-HTN therapy.
Study burden and risks
Patients enrolled in this study have a clinical indication for implant of a
permanent pacemaker and will therefore undergo the procedure required for
implantation of the Moderato system whether or not they participate in this
study. The potential added risks therefore relate to those associated with the
delivery of the Moderato-HTN signals. The two aspects of risks can be
summarized as follows:
Risks associated with Moderato implant (these are the risks to which the
patient would be exposed independent of participation in the study):
As with the placement of a standard pacemaker, there are risks of complications
that may occur during or after the procedure. With standard pacemakers these
complications are uncommon and they can usually be cured or treated. Possible
complications include infection, blood clots in the blood, damage of the heart
wall, technical problems with the pacemaker, lead dislodgement or lead
fracture, a reaction to drugs used during surgery, damage to the arteries or
veins in the implant site, and pacemaker syndrome (ie the patient has an oozing
sensation in the head, chest or abdomen and sometimes dizzy and tired
continued).
The potential added risks associate with Moderato-HTN therapy may include:
a. Development of heart failure
b. Palpitations
c. Low blood pressure
d. Stroke
e. Kidney Dysfunction
f. Development of unusual patient sensations, pain or discomfort
g. Device malfunction which may require device replacement or explantation
h. Heart attack
i. Arrhythmias, including atrial fibrillation, atrial tachycardia
j. Increase in heart rate due to activation of the neurohormonal system
Since the Moderato-HTN therapy is experimental, there may be risks that are not
yet known.
Pregnant women or women who may become pregnant during the study may only
participate if they are willing to use contraception during the course of the
study The doctor will discuss this further with the subject. If the subject
becomes pregnant during the study, she should immediately inform the study
doctor.
Benefits
The blood pressure may decrease as a result of the Moderato-HTN therapy. The
study will determine the degree to which this benefit can occur.
In addition, the subject will receive the Pacemaker trearment that he/ she
needs.
It is thanks to this type of research that better treatments for persistent
hypertension can be developed.
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 is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
3) Subject has stable (for prior 2 months) regimen of 2 or more maximally tolerated anti-hypertension medications (of different drug classes), which is anticipated to be able to be maintained without changes for 3 months.
4) Subject has office systolic blood pressure measurement > 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is >=150 mmHg. All measures are to be taken prior to morning medication (e.g. 7-10AM). If the average of the two systolic blood pressure measurements is not >=150 mmHg, or one of the BP readings is less than 140 mmHg, a third measurement can be taken, with the same stability criterion applied for study eligibility.
5) Proximity to study center which will permit compliance with study visits for at least 4 months.
Exclusion criteria
1) Subject has known secondary cause of HTN
2) Subject has a history in the past year of persistent atrial fibrillation or clinically significant paroxysmal atrial fibrillation (clinically significant paroxysmal atrial fibrillation is defined as atrial fibrillation that in the investigators judgment would prevent the delivery of the Backbeat HTN therapy for a significant amount of the time, over 25%).
3) Subject has ejection fraction <50%
4) Subject has symptoms of heart failure of NYHA Class II or more
5) Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness >=15 mm
6) Subject is on dialysis
7) Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2
8) Subject has prior neurological events (stroke or TIA) or carotid artery disease
9) Subject has known autonomic dysfunction
10) Subject has a history of clinically significant tachyarrhythmia and is not on a stable medical regimen
11) Subject has had previous active device-based treatment for hypertension
12) Subject has an existing implant, other than a pacemaker that needs replacing
13) 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.
14) Subject cannot or is unwilling to provide informed consent
15) Subject with average Systolic BP >190 mmHg
16) Subject is currently participating in another clinical study.
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 |
|---|---|
| CCMO | NL43708.018.13 |