The primary purposes of this study is to characterize the optimal electrode placement and electrode spacing on the lead*s spiral fixation such that at least one electrode on the spiral will contact the myocardium site in the coronary vein. Secondary…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objectives of this study is to characterize the electrical
performance of a dual zone, quadpolar lead design in order to specify the
electrode placement location on the spiral fixation of the lead body
Secondary outcome
The Secundary objectives of this study are to:
1. Evaluate the anatomic fit of the short and long straight tip leads
2. Measure the phrenic nerve stimulation threshold if it occurs during the
pacing threshold testing and evaluate ability to mitigate PNS by switching
pacing zones/locations
3. Evaluate the ability of the leads to be delivered and placed to the selected
sites within the coronary branch veins using the standard CRT delivery tools
and over-the-wire technique
Background summary
While recent advances in LV lead development now allow more flexibility in
placing a lead inside the coronary vein tree to find the viable myocardial
tissue and at the same time to avoid the phrenic nerve stimulation, the LV lead
still requires acute repositioning at least one-third of the time during CRT
implants. Left phrenic nerve stimulation continues to be the most common
complication of intraoperative and perioperative transvenous lead placements.
Despite attempts to avoid phrenic nerve stimulation during implant, it cannot
always be completely prevented, and Electronic Repositioning has proven to than
be an effective remedy.
The new lead design with the inclusion of four discrete electrodes is intended
to provide an implanting physician with a highly deliverable lead allowing
multiple pacing configuration options to mitigate phrenic nerve stimulation and
high thresholds.
Study objective
The primary purposes of this study is to characterize the optimal electrode
placement and electrode spacing on the lead*s spiral fixation such that at
least one electrode on the spiral will contact the myocardium site in the
coronary vein.
Secondary purposes of this clinical investigation are to evaluate other acute
pacing parameters including pacing impedance and sensing R-wave amplitude in
multiple configurations; phrenic nerve stimulation threshold; anatomical fit of
the different straight tip lengths; and handling characteristics of the new
lead design.
The data generated in the acute human study will be used to make
recommendations to the left ventricular (LV) lead product development project
regarding the lead design factors mentioned above.
Study design
The LILAC study is an acute, non-randomized, multicenter data collection
clinical investigation. All patients who are enrolled in the study undergo the
same study testing. There is no patient control group required.
The total duration of the study is expected to be 12 months.
Study burden and risks
Burden: the lengthening of the total duration of the standard implant procedure
by approximately 30 minutes
Risks:The major risks to the patients enrolled in this protocol are associated
with the catheterization procedures, which is part of the standard LV lead
implant procedures (see protocol page 31-32)
The risks associated with the lengthening of the total duration of the standard
implant procedure by approximately 30 minutes are similar. The study testing
will lead to a longer X-ray exposure.
Standard pacing threshold testing is part of any routine lead implant
procedure. According to this protocol, additional threshold tests are
performed, in order to characterize the lead design of three new prototypes.
There is a risk of arrhythmia due to pacing threshold testing. Should an
arrhythmia occur, the patient will be in a controlled clinical environment with
specialized equipment and will be treated in accordance with standard
procedures.
The risks associated with this trial are mitigated by the fact that no research
devices will be permanently implanted in the patient and all components
contacting the patient are sterile and used as per their individual
instructions for use.
Lambroekstraat 5D
1831 Diegem
BE
Lambroekstraat 5D
1831 Diegem
BE
Listed location countries
Age
Inclusion criteria
• Patients who are scheduled to receive (new implant or upgrade) either CRT-P or CRT-D system based on physician discretion
• Patients who are scheduled to have an LV lead implantation based on physician discretion
• Patients who are expected to tolerate approximately 30 minutes of study testing procedures per physician discretion
• Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center
• Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
• Patients who are allergic to the contrast media used in the study
• Patients who have a history of pocket or device related infection
• Patients who have any previous cardiac surgery within the last 3 months
• Patients who have concomitant cardiac surgery
• Patients who have unstable angina
• Patients who have myocardial infarction within the last 3 months
• Patients who are dependent on IV inotropes
• Patients who are in acute cardiac failure crisis
• Women of childbearing potential who are, or might be, pregnant at the time of the study (method of assessment upon physician*s discretion)
• Patients whose age is more than 80 years
• NYHA class IV patients
• Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study
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 | NL31566.068.10 |