The primary objectives of this study are to confirm the clinic al safety and effectiveness of the Aveir LP system in subjects who are indicated for VVI(R) pacemaker.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The confirmatory safety endpoint evaluates the 12-month complication-free rate.
The confirmatory effectiveness endpoint evaluates pacing thresholds and R-wave
amplitudes within the therapeutic range through 12-months post-implant.
Secondary outcome
The confirmatory secondary endpoint evaluates an appropriate and proportional
rate response during graded exercise testing (CAEP protocol), performed between
the 6-week and 3-month visit.
Background summary
The clinical investigation for the IDE application to support the evaluation of
the safety and effectiveness of the St. Jude Medical LP system for treatment of
bradycardia consists of two phases:
Phase 1 included the evaluation of St. Jude Medical*s original NanostimTM
Leadless Pacemaker system consisting of LP Model S1DLCP and its supporting
accessories (ClinicalTrials.gov identifier: NCT02030418). As of this protocol,
Phase 1 has completed the primary safety and effectiveness endpoint analyses,
submitted the PMA application, and is currently under the Continued Access
Phase (CAP). Due to device malfunctions related to the battery and docking
button, the Nanostim system was discontinued.
Phase 2 is described within this clinical investigational plan and includes the
confirmatory evaluation of the modified St. Jude Medical LP system consisting
of a modified LP, model LSP112V and its supporting accessories, herein referred
to as the AveirTM Leadless Pacemaker System. Study subjects who are newly
implanted (de novo) with the Aveir LP will contribute to the confirmatory
endpoints and follow Phase 2 protocol requirements. European subjects enrolled
in the Leadless Observational Study (NCT#02051972) involving the original
Nanostim LP who need replacement of their Nanostim LP with the Aveir LP may be
enrolled in this IDE only after the confirmatory enrollments have been
completed for Phase 2 (i.e. during the CAP for Phase 2).
Study objective
The primary objectives of this study are to confirm the clinic al safety and
effectiveness of the Aveir LP system in subjects who are indicated for VVI(R)
pacemaker.
Study design
The Leadless II Study - Phase 2 is a prospective, non-randomized, multi-center,
international clinical study
Intervention
Implantation of an Aveir leadless pacemaker - model LSP112V
Study burden and risks
The patients will visit the hospital at 3 additional timepoints in the first
year for a study visit, compared to patients who receive a wireless pacemaker
according to standard care. The visits 6 months after an annual check-up are
also extra compared to the standard care.
The risks of implantation are comparable to those of implantation of wireless
pacemakers that are commercially available.
This study includes exposure to radiation for X-rays and pictures of the chest.
The radiation dose in this study is comparable to that of currently approved
pacemaker implantation and follow-up procedures.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1 Subject must have one of the clinical indications before device implant in
adherence
with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:
* Chronic and/or permanent atrial fibrillation with 2 or 3° AV or
bifascicular bundle branch block
(BBB block), including slow ventricular rates (with or without
medication) associated with atrial
fibrillation; or
* Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of
physical activity or short
expected lifespan (but at least one year); or
* Sinus bradycardia with infrequent pauses or unexplained syncope with EP
findings; and
2. Subject is >=18 years of age; and
3. Subject has a life expectancy of at least one year; and
4. * Subject is not be enrolled in another clinical investigation; and
5. Subject is willing to comply with clinical investigation procedures and
agrees to return for all
required follow-up visits, tests, and exams; and
6. Subject has been informed of the nature of the study, agrees to its
provisions and has provided a
signed written informed consent, approved by the IRB; and
7. Subject is not pregnant and does not plan to get pregnant during the course
of the study.
* Except for subjects who are enrolled in the Leadless Observational Study and
need their existing Nanostim LP replaced with the Aveir LP. These subjects may
only be enrolled in this IDE during the CAP study of Phase 2.
Exclusion criteria
1. Subject has known pacemaker syndrome, has retrograde VA conduction, or
suffers a
drop in arterial blood pressure with the onset of ventricular pacing; or
2. Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium
phosphate
(DSP);
3. Subject has a mechanical tricuspid valve prosthesis; or
4. Subject has a pre-existing endocardial pacing or defibrillation leads; or
5. Subject has current implantation of either conventional or subcutaneous
implantable cardioverter
defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
6. Subject has an implanted vena cava filter; or
7. Subject has evidence of thrombosis in one of the veins used for access
during the procedure; or
8. Subject had recent cardiovascular or peripheral vascular surgery within 30
days of
enrollment; or
9. * Subject has an implanted leadless cardiac pacemaker
10.* Subject is implanted with an electrically-active implantable medical
device with stimulation
capabilities (such as neurological or cardiac stimulators).
* Except for subjects who are enrolled in the Leadless Observational Study and
need their existing Nanostim LP replaced with the Aveir LP. These subjects may
only be enrolled in this IDE during the CAP study of Phase 2.
* Does not apply to a medical device known to not be impacted by the AveirTM
Link Module telemetry signals or to a medical device than can be temporarily
turned off during interrogation/programming of an AveirTM LP.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT02030418 |
| CCMO | NL75132.018.20 |