To evaluate the safety and clinical performance of the LCP system in patients 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 primary safety endpoint is to evaluate a 90-day complication rate, where a
complication is defined as a serious adverse device effect (SADE)
Secondary outcome
To report pacing, sensing, and rate-response performance, implant success rate,
and safety analysis with reporting of all adverse events.
Background summary
The normal heart rhythm can be disturbed due to disease or aging.
This can result in problems with the conduction system of the heart. The
impulse from the sinus node can be delayed or even blocked passed. This causes
a slow and / or irregular heartbeat. A solution is a pacemaker. The pacemaker
functions as a guardian of the heart rhythm by continuously monitoring the
heart rate and, if necessary, regulate the heart rhythm.
Most of the complications of a standard pacemaker, are due to the electrode
wires (leads). Nanostim has developed a leadless pacemaker which should
encounter these specific complications.
Study objective
To evaluate the safety and clinical performance of the LCP system in patients
who are indicated for VVI(R) pacemaker.
Study design
Prospective, non-randomized, single-arm, multicenter study.
Intervention
Percutaneous insertion of the leadless LCP system.
Study burden and risks
There is no guarantee that the subject will benefit of participating in the
research . It is possible that the risk of an irregular or slow heartbeat,
which can cause dizziness, fainting, extreme fatigue and shortness of breath,
decreases.
It is thanks to this type of research that better treatments for irregular or
slow heartbeat can be developed.
Every medical procedure carries risks with it. Since the Nanostim pacemaker is
an investigational device, some risks are not known. As with any surgery, there
may be complications during or after pacemaker implantation. Fortunately this
is not common and they can usually be treated or corrected. Possible
complications include:
* infection
The biggest risk is a replacement of the pacemaker;
* clot formation in the blood
* damage of the heart wall
* technical problems with the pacemaker
* blood loss as a result of the (after) bleeding from the surgical wound
* a reaction to the medications used during surgery;
* The pacemaker syndrome: The patient gets a pounding feeling in head, chest or
abdomen and sometimes dizzy and constantly tired .
In this clinical trial, there is a small amount of exposure to radiation during
angiography (X-ray of the arteries). In daily life, everyone is exposed to
natural background radiation and it is exposed to a dose of about 2
millisieverts (mSv: is a measure of radiation) per year. The effective dose
resulting from this treatment is estimated at a maximum of 0.4 mSv.
Pregnant women are excluded from this study. This applies to the entire study.
It is not known what the consequences of participating in the study are to your
unborn child.
The study doctor will discuss the procedure and the potential complications
extensively discuss with the patient.
Palomar Avenue 776
Sunnyvale 94085
US
Palomar Avenue 776
Sunnyvale 94085
US
Listed location countries
Age
Inclusion criteria
1. Subject must have one of the following clinical indications:
* Chronic atrial fibrillation1 with 2 or 3° AV or bifascicular bundle branch block (BBB block)2; 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 *18 years of age; and
3. Subject has life expectancy of at least one year; and
4. Subject is not 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 written informed consent, approved by the EC; and
7. If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.
Exclusion criteria
1. Pacemaker dependent; or
2. Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; or
3. Hypersensitivity to < 1 mg of dexamethasone sodium phosphate; or
4. Mechanical tricuspid valve prosthesis; or
5. Pre-existing pulmonary arterial (PA) hypertension3 or significant physiologically-
impairing lung disease; or
6. Pre-existing pacing or defibrillation leads; or
7. Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
8. Presence of implanted vena cava filter; or
9. Presence of implanted leadless cardiac pacemaker; or
10. Pregnant or breastfeeding.
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 | NCT01700244 |
| CCMO | NL42207.018.12 |