The purpose of this study is to evaluate the safety and effectiveness of the Aveir wireless dual-chamber pacemaker system in the treatment of patients with slow or irregular heartbeats.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint evaluates the 12-month Aveir DR LP system
complication-free-rate in de novo subjects based on CEC adjudication of adverse
events.
The primary effectiveness endpoint #1 evaluates the 12-month composite success
rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo
subjects.
The primary effectiveness endpoint #2 evaluates the 3-month AV synchrony
success rate at rest while seated in de novo subjects.
Secondary outcome
The secondary safety endpoint evaluates the 12-month Aveir atrial LP
complication free rate in de novo subjects based on CEC adjudication of adverse
events.
The secondary effectiveness endpoint evaluates the appropriate and proportional
rate response of the atrial LP in de novo subjects during graded exercise
testing (chronotropic assessment exercise protocol *CAEP*).
Background summary
Cardiac pacing has been an established therapy for patients with
bradyarrhythmia for over 50 years. However, this life-improving therapy is
still associated with significant complications, primarily related to the
transvenous lead and the subcutaneous pulse generator pocket.
Short-term complication rates as high as 8% to 12% have been reported, and
include pneumothorax, cardiac tamponade, pocket hematoma, and lead
dislodgement. In the long term, these leads are also prone to insulation breaks
and conductor fracture, requiring re-intervention that puts the patient at risk
for significant morbidity. Furthermore, 0.7% to 2.4% of patients encounter
serious complications related to the subcutaneously placed pulse generator that
include skin erosion, pocket infection, and septicemia.
The complications associated with the conventional transvenous pacemaker design
have triggered the clinical need to eliminate the pacemaker lead, pockets and
connectors through a fully self-contained leadless pacemaker system that can be
implanted percutaneously with a steerable catheter, thus offering patients a
less-invasive approach as compared to conventional pacemaker procedures that
require more extensive surgery. The leadless concept was also designed to
improve patient comfort by eliminating the visible lump and scar at a
conventional pacemaker*s pectoral implant site and by removing the need for
activity restrictions to prevent dislodgement or damage of a conventional lead.
As of the end of 2020, only two single-chamber leadless pacemaker models are
commercially available while others are in development or under clinical
investigation. Despite the cardiac rhythm management advances demonstrated from
conventional transvenous pacemaker to single chamber leadless pacemaker
systems, most patients require dual chamber pacing because of their clinical
presentation.
Patients who are indicated for dual-chamber pacing would benefit from a
dual-chamber leadless pacemaker system that provides atrial and ventricular
bradycardia therapy while eliminating the long-term complications associated
with the surgical pocket and transvenous atrial and ventricular leads that are
associated with conventional pacing systems.
Currently, there are no leadless pacing systems capable of DDD(R) pacing. The
Aveir DR LP system is a promising new technology that can deliver DDD(R) pacing
therapy while also offering advantages over transvenous dual-chamber pacemakers
for the treatment of bradyarrhythmias. The Aveir DR LP system is expected to
provide comparable bradycardia treatment as transvenous dual-chamber pacemakers
for patients indicated for similar conditions.
Study objective
The purpose of this study is to evaluate the safety and effectiveness of the
Aveir wireless dual-chamber pacemaker system in the treatment of patients with
slow or irregular heartbeats.
Study design
This is a prospective, multi-center, international, single-arm, pivotal
investigational study designed to evaluate the safety and effectiveness of the
Aveir DR LP system in a subject population indicated for a DDD(R) pacemaker.
Intervention
2 Leadless pacemakers are implanted in all subjects. If a subject already has a
leadless Aveir implanted, a second Aveir is placed in the right atrium.
Study burden and risks
Possible risks and discomforts associated with participation in the study will
be similar to those associated with any routine dual-chamber pacemaker
implantation procedure and related follow-up procedures. For the study there is
an additional visit to the hospital after the implant-procedure, compared to
the standard of care after implant of a traditional pacemaker.
Study-specific assessments that are not considered standard of care include
femoral vein access instead of subclavian vein access, six-minute walk test and
treadmill tests for rate response evaluation, in-clinic AV Synchrony
assessments, 24-hour Holter monitoring, and EQ-5D quality of life assessment.
A subject may experience fatigue, shortness of breath, chest pain and/or leg
cramps during six minute walk and treadmill tests; this is mitigated by
performing this test under the supervision of a trained professional and in a
testing area where medical care is immediately available.
It is concluded from preclinical data (risk analysis and literature review)
that clinical risks are comparable to those associated with currently available
therapy (transvenous dual-chamber pacing). Uncertainty exists in relation to
risks associated with novel features (percutaneous delivery via a femoral vein
and the possibility dislodgement or migration). These residual risks cannot be
estimated with confidence without data from a clinical investigation. Taking
into account the nature of the possible harm that could arise from these
device-related risks and the assurance provided by pre-clinical data, the
risk-benefit balance associated with the use of the LP in a clinical trial is
considered to be favorable.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Subject must have at least one of the clinical indications before device
implant in adherence
with ACC/AHA/HRS/ESC dual chamber pacing guidelines
2. Subject is >= 18 years of age or age of legal consent, whichever age is
greater
3. Subject has a life expectancy of at least one year
4. Subject is willing to comply with clinical investigation procedures and
agrees to return to clinic
for all required follow-up visits, tests, and exams
5. Subject has been informed of the nature of the clinical investigation,
agrees to its provisions
and has provided a signed written informed consent, approved by the
IRB/EC
Exclusion criteria
1. Subject is currently participating in another clinical investigation that
may confound the results
of this study as determined by the Sponsor
2. Subject is pregnant or nursing and those who plan pregnancy during the
clinical investigation
follow-up period
3. Subject has presence of anatomic or comorbid conditions, or other medical,
social, or
psychological conditions that, in the investigator*s opinion, could
confound the assessment of
the investigational device and/or implant procedure, limit the
subject*s ability to participate in
the clinical investigation or to comply with follow-up requirements of
the clinical investigation
results
4. Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone
sodium
phosphate or any blood or tissue contacting material listed in the IFU
5. Subject has an implanted vena cava filter or mechanical tricuspid valve
prosthesis
6. Subject has pre-existing, permanent endocardial pacing or defibrillation
leads (does not include
lead fragments)
7. Subject has current implantation of either conventional or subcutaneous
implantable
cardioverter defibrillator (ICD) or cardiac resynchronization therapy
(CRT) device
8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir
ventricular LP)
9. Subject is implanted with an electrically-active implantable medical device
with stimulation
capabilities (such as neurological or cardiac stimulators)*
10. Subject is unable to read or write
*NOTE: Does not apply to a medical device with no known impact to the Aveir
Leadless Pacemaker System, including the Aveir Link Module. Patient evaluation
and the decision to implant the LP should take into account the presence of
other active implantable devices and should include consultation with the
Sponsor and/or manufacturer of the co-existing device.
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | NL79310.000.21 |