5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
20.4 Primary endpoint(s) analysis
20.4.1 Safety
Primary endpoint - Device-related complications (24 hours perioperative and one
month):
A primary endpoint for evidence of safety will be the number of patients with
major device-related complications. This endpoint will be assessed at two time
points, the perioperative device-related complications (from implant to 24
hours post implant) and the one month (30 day) device-related complications
(from 24 hours post implant to 30 days post implant). The definition of a major
device-related complication is a complication in which the WiCS-LV system is
directly or indirectly responsible for a serious adverse event. All serious
adverse events will be reviewed and adjudicated by an independent Clinical
Events Committee.
Primary endpoint - Procedure-related complications (24 hours perioperative and
one month):
A primary endpoint for evidence of safety will be the number of patients with
major procedure-related complications. This endpoint will be assessed at two
time points, the perioperative procedure-related complications (from implant to
24 hours post implant) and the one month (30 day) procedure-related
complications (from24 hours post implant to 30 days post implant). The
definition of a major procedure-related complication is a serious adverse event
occurring as a direct result of the implant procedure. All serious adverse
events will be reviewed and adjudicated by an independent Clinical Events
Committee.
20.4.2 Performance
Primary endpoint - bi-ventricular pacing at one month:
The primary endpoint for evidence of clinical performance will be chronic
bi-ventricular pacing. This will be demonstrated by obtaining 12 lead EKG*s at
the 1 month (30 day) follow-up assessment. Twelve lead EKG*s will be obtained
without pacing (if the patient is not pacemaker-dependent, during RV pacing (by
temporarily programming off the WiCS-LV system), and during bi-ventricular
pacing. Bi-ventricular capture will be demonstrated by comparing the paced QRS
morphology during bi-ventricular pacing to that during RV-only pacing. Note
that in order to meet this endpoint, two performance criteria are met, both the
appropriate recognition of the co-implant RV pacing output (successful
detection) and LV pacing (successful capture).
Secondary outcome
20.5 Secondary endpoint(s) analysis
20.5.1 Safety
Secondary endpoint - Device-related complications up to 6 months:
Device-related complications will be tabulated in the same manner as the
primary endpoint, but extended to 6 months post implant. All serious adverse
events will be reviewed and adjudicated by an independent Clinical Events
Committee.
Secondary endpoint - Major complications up to 6 months:
All serious adverse events regardless of cause will be tabulated. All serious
adverse events will be reviewed and adjudicated by an independent Clinical
Events Committee.
Surveillance evaluation annually for 5 years:
All serious adverse events will be tabulated. Data regarding battery depletion
and device replacement will be collected.
20.5.2 Performance
Secondary endpoint - left ventricular pacing at one, 2 and 6 months:
The secondary endpoint for evidence of clinical performance will be chronic
left ventricular pacing. This will be demonstrated by obtaining 12 lead EKG*s
at the one, 2 and 6 month follow-up assessments. Normally, the 12 lead EKG will
be obtained after temporarily reducing the co-implanted pacemaker rate and
operating the WiCS-LV system in temporary VOO mode at a higher rate to capture
the left ventricle alone. However, there may be instances where it is
clinically preferable to demonstrate left ventricular capture by comparing the
paced QRS morphology during bi-ventricular pacing to that during right
ventricular pacing alone (by temporarily programming off the WiCS-LV system).
Secondary endpoint - bi-ventricular pacing at 2 and 6 months:
Bi-ventricular pacing as a secondary endpoint will be demonstrated by obtaining
12 lead EKG*s at the 2 and 6 month follow-up assessments. Twelve lead EKG*s
will be obtained without pacing (if the patient is not pacemaker-dependent,
during RV pacing (by temporarily programming off the WiCS-LV system), and
during bi-ventricular pacing. Bi-ventricular capture will be demonstrated by
comparing the paced QRS morphology during bi-ventricular pacing to that during
RV-only pacing. Note that in order to meet this endpoint, two performance
criteria are met, both the appropriate recognition of the co-implant RV pacing
output (successful detection) and LV pacing (successful capture).
20.5.3 Preliminary Evidence of Efficacy
Secondary endpoint - Clinical composite score at 6 months:
The clinical composite score is a measure incorporating the parameters of all
cause mortality, hospitalizations for heart failure, NYHA functional
classification, and patient global assessment (29). The clinical composite
score has been utilized as an endpoint in a number of clinical studies of CRT
device systems (4,5,30). The NYHA functional classification assigns patients to
one of four classes (I, II, III, or IV) depending on the degree of symptoms
needed to elicit symptoms (28). The patient global assessment is a measure of
the whether the patient*s overall status has changed since the start of the
study, and if so, in which direction and to what magnitude. The NYHA
classification and patient global assessment will be made by the Investigator.
The clinical composite score classifies the patient as improved, unchanged, or
worsened depending on the clinical response during and the clinical status at 6
months. Patients are considered improved if at 6 months the NYHA class is
decreased by at least one class or the patient global assessment is better (or
both) and they did not experience mortality or hospitalization for heart
failure.
Secondary endpoint - Change in echocardiographic left ventricular end-systolic
volume, left ventricular end-diastolic volume, and ejection fraction at 6
months:
The values of the above parameters obtained from the pre-implant study will be
compared to the values obtained after 6 months as a measure of cardiac reverse
remodeling. A reduction in LV end-systolic volume and/or end-diastolic volume
of >= 10% will be considered a positive echocardiographic response (31). An
absolute increase in EF by >= 5% will also be considered a positive
echocardiographic response.
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
5.1 Primary study objectives:
5.1.1 Safety
Safety of the device has been defined as
1. Device-related complications (24 hour perioperative and one month)
2. Procedure-related complications (24 hour perioperative and one
month)
5.1.2 Performance
Performance of the device has been defined as:
1. Bi-ventricular pacing capture (documented on 12 lead EKG at one month)
5.2 Secondary study objectives:
5.2.1 Safety
1. Device-related complications up to 6 months
2. Major complications up to 6 months
3. Surveillance by annual registry survey
5.2.2 Performance
1. Left ventricular pacing capture (documented on 12 lead EKG at one, 2
and 6 months)
2. Bi-ventricular pacing capture (documented on 12 lead EKG at 6 months)
5.2.3 Preliminary evidence of 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
Study design
This study is a multicenter, prospective, open-label, and non-comparative
clinical investigation. The study will be conducted in up to 7 clinical
centers in EU member states.
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.
Intervention
Summary of implant steps:
1. Prepare femoral artery access with introducer and arterial closure device.
2. Administer intravenous heparin to attain an ACT level in the range of
200-250 sec.
3. Introduce Delivery System*s Sheath and Dilator into femoral artery
introducer and advance into the artery.
4. Inflate Sheath*s distal tip balloon and then advance Sheath and Dilator into
the LV.
5. Exchange Dilator for the Catheter mounted with the Electrode and position
the Sheath at target LV implant site.
6. Evaluate intracardiac electrogram with the Electrode.
7. Perform transthoracic echocardiography imaging of the Electrode in the
Sheath with a commercial instrument to confirm a Transmitter acoustic window
location on the chest wall.
8. Anchor the Electrode into the LV tissue, confirm tissue attachment using
contrast dye, and confirm intracardiac electrogram and acceptable electrical
pacing thresholds.
9. Disconnect the Electrode from the Catheter.
10. Release the Electrode from the Sheath.
11. Retract the Sheath and Catheter in to the femoral artery and deflate the
Sheath*s distal tip balloon.
12. Remove the Delivery Catheter System via the femoral introducer.
13. Perform transthoracic echocardiography imaging of the Electrode implanted
in the LV with a commercial instrument to determine the Transmitter acoustic
window location on the chest wall and mark the chest location.
14. After ACT level is lowered to an acceptable level (approximately 180 sec),
make skin incisions and subcutaneous pockets for the Transmitter and Battery
modules.
15. Tunnel the cable to the lateral Battery pocket using standard techniques
with a trocar or other suitable blunt instrument.
16. Insert Battery into the lateral Battery pocket, connect to Transmitter
cable, and secure cable in place.
17. Insert the Transmitter stability accessory into the intercostal space and
secure to the intercostal muscle.
18. Insert and secure Transmitter into the accessory. Fill area with saline or
sterile conductive gel.Using the Programmer, evaluate RV pacing detection and
LV pacing capture.
19. Demonstrate bi-ventricular pacing capture as recorded on EKG.
20. Secure Battery in place and close skin incisions. Optionally, a drain
and/or negative pressure bandage may be applied to eliminate air around the
implanted Transmitter.
21. Document final program settings for WiCS-LV and co-implant.
At the discretion of the operator, the implant procedure may be assisted by
transesophageal echocardiography or intracardiac ultrasound.
Study burden 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:
• Implanted Electrode may 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. Additionally, warnings are placed in the Technical Manual
and Investigators are trained for this specific risk.
WEST MAUDE AVE. 686
SUNNYVALE, CA 94085
US
WEST MAUDE AVE. 686
SUNNYVALE, CA 94085
US
Listed location countries
Age
Inclusion criteria
Patients with standard indications for CRT based upon the most recent ESC/EHRA guidelines AND meeting criteria for one of these two categories:
1. Patients with previously implanted pacemakers or ICD*s and meeting standard indications for CRT but in whom standard CRT is not advisable due to known high risk - referred to as *upgrades*. Justifications for not using standard CRT must be documented in a CRF.
2. Patients in whom coronary sinus lead implantation or attempted implantation for CRT has failed to provide demonstrable therapy benefit - referred to as *untreated*
Investigator
Exclusion criteria
Study patients responding to the following criteria are excluded from enrollment:
1. Inability to comply with the study follow-up or other study requirements
2. History of chronic alcohol/drug abuse and currently using alcohol/drugs
3. Non-ambulatory (or unstable) NYHA class 4
4. Contraindication to heparin
5. Contraindication to both chronic anticoagulants and antiplatelet agents
6. Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents)
7. Thrombocytopenia (platelet count <150,000)
8. Contraindication to iodinated contrast agents
9. Intracardiac thrombus by transesophageal echocardiography
10. Age less than 18 years or greater than 75
11. Attempted IPG implant within 3 days
12. Life expectancy of less than 12 months
13. Chronic hemodialysis
14. Stage 4 or 5 renal dysfunction defined as GFR <30
15. Grade 4 mitral valve regurgitation
16. Myocardial infarction within one month
17. Major cardiac surgery within one month
18. History of a pericardial effusion in prior procedures
19. Female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable)
20. Non-cardiac 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 | NL44156.075.13 |