The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study objectives:
Safety
Safety of the device has been defined as
- Device-related complications (24 hour peri-operative and one
month)
- Procedure -related complications (24 hour peri-operative and one
month)
Performance
Performance of the device has been defined as:
- Bi-ventricular pacing capture (documented on 12 lead EKG at one
month)
Secondary outcome
Secondary study objectives:
Safety
1.Device-related complications up to 6 months
2. Major complications up to 6 months
3. Surveillance evaluation annually for 5 years
Performance
1. Left ventricular pacing capture (documented on 12 lead EKG at one,
3 and 6 months)
2. Bi-ventricular pacing capture (documented on 12 lead EKG at 3 and
6 months)
3. Bi-ventricular pacing on 24 hour ambulatory monitoring at 1, 3,
and 6 month
Preliminary efficacy
1. Clinical composite score (all cause mortality, HF hospitalization,
NYHA class, and patient global assessment (16)) at 6 months
2. Change in echocardiographic left ventricular end-systolic volume,
left ventricular end-diastolic volume, and ejection fraction at 6 months
3. Change in blood laboratory Brain Natriuretic Peptide (NT-proBNP)
at 6 months
Background summary
Bi-ventricular pacing is the pacing modality used to accomplish Cardiac
Resynchronization Therapy (CRT). CRT is recommended for use by both European
Society of Cardiology/European Heart Rhythm Association (ESC/EHRA) Guidelines
and ACC/AHA/HRS Guidelines for a number of subsets of heart failure patients
based on evidence from large scale randomized trials demonstrating benefits in
symptoms, function, and survival.
Study objective
The purpose of this Clinical Investigation Plan is to collect data on the
safety and performance of the WiCS-LV system. It is designed to satisfy
requirements for clinical data and post market clinical follow-up for the
Active Implantable Medical Devices Directive (AIMDD 90/385/EEC), Annex 7, as
amended in December 2008. A complete risk assessment was performed to
determine the design of the Clinical Investigation Plan.
Study design
This study is a multicenter, prospective, open-label, non-comparative clinical
investigation,
conducted in up to 11 clinical sites in Europe and one clinical site in Hong
Kong, Republic of China.
Intervention
Pre-implant visit
•Physical exam
•Cardiac medications
•Chest X-ray
•EKG*s
•Global assessment
•NYHA functional class
•Echocardiogram
•Blood specimens (serum creatinine, electrolytes, BUN, platelet count,
NT-proBNP)
Pre-discharge visit
•Physical exam
•Cardiac medications
•Chest X-ray
•EKG*s
•Blood specimens (serum creatinine, electrolytes, BUN)
•WiCS, co-implant device checks
•Adverse events
1-month follow-up visit (± 1 week)
•EKG*s
•24 hr ambulatory monitor
•WiCS, co-implant device checks
•Adverse events
3-month follow-up visit (± 2 week)
•EKG*s
•24 hr ambulatory monitor
•NYHA functional class
•WiCS, co-implant device checks
•Adverse events
6-month follow-up visit (± 1 month)
•Physical exam
•Cardiac medications
•EKG*s
•24 hr ambulatory monitor
•Global assessment
•NYHA functional class
•Echocardiogram
•Blood specimens (NT-proBNP)
•WiCS, co-implant device checks
•Adverse events
1, 2, 3, 4, 5 year follow-up visit (± 2 month)
•Cardiac medications
•EKG*s
•Global assessment
•NYHA functional class
•Echocardiogram
•Blood specimens (NT-proBNP)
•WiCS, co-implant device checks
•Adverse events
Study burden and risks
Patient Benefit and Risks
A risk analysis according to ISO 14971 Application of risk management to
medical devices has been conducted. Risks have been proven minimized or
eliminated through appropriate design control, confirmed by pre-clinical bench,
laboratory and animal testing.
Discomforts and Risks
The WiCS-LV system is associated with some potential discomforts and risks
common to all implantable pacing systems, as well as certain unique potential
discomforts and risks.
Potential discomforts and risks common to all implantable pacing systems
include the following:
Air embolism
Allergic reactions to medications used including renal failure from contrast
media
Arrhythmias
Cardiac tamponade
Chronic nerve damage
Death
Electrochemical burns
Excessive bleeding
Excessive fibrotic growth
Foreign body reaction
Hematoma
Embolization of device or materials
Infection
Migration of device
Myocardial tissue injury or perforation
Myocardial infarction
Pain
Pneumothorax
Radiation skin burns
Stroke or transient cerebrovascular episodes
Thromboembolism
Vascular damage
Potential discomforts and risks of the WiCS-LV system not associated with
implantable pacing systems but having similarities to left heart
catheterization or the implantation of other devices within the left heart
(such as stents, clips, septal closure devices, and appendage occlusion
devices) include the following:
Aortic or mitral valve damage
Dissection of aorta or branch vessels
Femoral artery pseudoaneurysm
Embolization of device or material, thrombi, or air to systemic circulation
increasing stroke and peripheral vascular occlusion risk
Potential discomforts and risks of the WiCS-LV system not associated with
implantable pacing systems but having similarities to other diagnostic and
therapeutic devices utilizing ultrasound energy (such as ultrasound imaging
instruments, physical therapy) related to ultrasound bioeffects include the
following:
Thermal injury from ultrasonic transducer elements overheating
Mechanical injury causing tissue damage
These risks are minimized by operating at substantially lower levels (duty
cycle and amplitudes) than those used in commercially available
echocardiographic imaging instruments. The system has safeguard circuitry to
prevent energy levels from exceeding programmed limits.
There is one potential risk of the WiCS-LV system not associated with other
devices:
There is a risk that an implanted Electrode will receive ultrasound pulses from
other ultrasound devices (such as echocardiographic imaging instruments) and
convert those pulses to stimulation pulses. This risk is minimized by the very
short, narrow pulse durations used in echocardiographic imaging devices and by
limiting the electrical output of the Electrode to amplitudes lower than the
expected stimulation thresholds at these pulse durations.
Potential Benefit
Left ventricular endocardial stimulation using wireless transmission of
ultrasound energy in combination with a conventional pacing system is an
investigational, non-approved means to accomplish Cardiac Resynchronization
Therapy i.e. bi-ventricular cardiac pacing for the treatment of heart failure.
CRT in general has been shown to improve patient symptoms, function, and
survival (3-11). Small published studies have suggested that CRT using
endocardial LV stimulation is associated with better LV function (17-20). The
potential for clinical benefit using the approach in this clinical
investigation is unknown.
686 W. Maude Avenue, Suite 102
CA 94085 Sunnyvale
US
686 W. Maude Avenue, Suite 102
CA 94085 Sunnyvale
US
Listed location countries
Age
Inclusion criteria
In this study, patients providing informed consent will be enrolled responding to the following criteria:;Patients with standard indications for CRT based upon the most recent ESC/EHRA guidelines AND meeting criteria for one of these three categories:
1. Patients with previously implanted pacemakers or ICD*s and meeting standard indications for CRT - referred to as *upgrades*
2. Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as *untreated*
3. Patients with previously implanted CRT device, not responding to CRT (no change or worsening of symptom or NYHA functional class after 6 months of treatment confirmed by investigator) - referred to as *non-responders*;Previously implanted or newly implanted CRT*s, pacemakers and ICD devices must provides dual-chamber pacing (RA and RV) if the patient has sinus rhythm, single-chamber pacing (RV) if the patient is in permanent AF
Exclusion criteria
Study patients responding to the following criteria are excluded from participation:
1. Inability to comply with the study follow-up or other study requirements
2. Contraindication to heparin
3. Contraindication to both chronic anticoagulants and antiplatelet agents
4. Contraindication to iodinated contrast agents
5. Intracardiac thrombus by transesophageal echocardiography
6. Age less than 18 years
7. Attempted IPG implant within 3 days
8. Life expectancy of < 12 months
9. Chronic hemodialysis
10. Myocardial infarction within one month
11. Major cardiac surgery within one month
12. Female of childbearing potential, pregnant, or breastfeeding
13. Noncardiac implanted electrical stimulation therapy devices
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 | NL32645.075.10 |