Demonstrate that the usage of a quadripolar LV lead results in easier LV lead implantation procedure and less chronic LV lead related adverse events in comparison with a traditional biventricular left ventricle lead.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival from the composite endpoint of intra*operative and post*operative
endpoints.
Intra*operative LV lead related endpoint:
* Due to phrenic nerve stimulation, lead instability or high capture threshold:
o Changing to a different tributary vein of the coronary sinus following site
evaluation
o Using more than one LV lead during the procedure for any reason.
o Using any device (eg. a stent) to actively fixate the lead
* Unsuccessful implant for any reason
Post*operative:
Any serious adverse device effect (SADE) related to the LV lead
Abandoned CRT for any reason
Secondary outcome
* % of CRT responders (defined as patients with a reduction in LVESV of at
least 10% between
baseline and the 6*month follow*up visit)
* % of patients with % of Biventricular Pacing >90% at 6 months post implant
* Implant procedure duration (skin to skin)
* Implant fluoroscopy time
* Repositioning the lead within the same vein (following unsatisfactory lead
site evaluation)
* Final LV lead position
* Reprogramming of the LV output to <1V above the measured pacing threshold
* Improvements in Quality of Life (MLWHF, EQ*5D) between baseline (BASE) and at
6 months
follow up visit (6M FUP)
* Survival from HF hospitalizations at 6M FUP
* Survival from CRT system related hospitalizations at 6M FUP
* Survival from all cause mortality at 6M FUP
Background summary
Cardiac Resynchronisation Therapy (CRT) is a recognised and rapidly expanding
therapy for heart failure (HF), it reduces death, HF hospitalisation and all
cause mortality. Left Ventricular (LV) leads cannot be implanted in up to 10%
of patients undergoing a
trans*venous system implantation. Even in studies that report a 96.5% success
rate, there are 10.5% of patients that require multiple procedures before a
lead is successfully implanted. These implant failures are not due to patient
selection, but rather challenges posed by anatomy leading to lead stability
problems, phrenic nerve stimulation and poor electrical measurements. Lead
repositioning in the same
coronary sinus (CS) side*branch (in 26%) may be needed in case of poor lead
stability, phrenic nerve stimulation (PNS) or unsatisfactory electric
measurements(9) . 17% of leads can require a change from the first accessed
vein to a second during the implant procedure due to unsatisfactory parameters.
In many patients phrenic nerve stimulation is not identified until after the
implant procedure, when movement and postural changes bring the pacing lead
into closer contact with the phrenic nerve. Many can only be managed via a
further invasive procedure (associated with a not insignificant infection risk)
to reposition the lead and if this approach is not successful then a minor
surgical procedure may be indicated to place a lead on the epicardial surface
of the heart. The Quartet® quadripolar electrode lead provides an opportunity
to address implant challenges, such as phrenic nerve stimulation and
unsatisfactory electrical measurements at implant, by programming pacing from
one of 10 bipolar electrode configurations (rather than three) utilising one of
the four lead electrodes as a pacing cathode. The increased programming
possibilities provided by using a quadripolar electrode lead instead of
traditional bipolar leads may provide non invasive alternatives in the
management of these challenges, reducing time spent addressing the problems and
the number of costly re*intervention procedures.
Study objective
Demonstrate that the usage of a quadripolar LV lead results in easier LV lead
implantation procedure and less chronic LV lead related adverse events in
comparison with a traditional biventricular left ventricle lead.
Study design
A prospective, randomized, open label, multicenter trial
Intervention
Implantation of a CRT-D device with a quadripolar LV Lead (treatment group) or
with a traditional biventricular LV lead (control group).
Study burden and risks
The risk is comparable to the risk of a standard CRT-D implantation. In
addition to the normal treatment patients will have a quality of Life
questionnaire taken at baseline and at 6 month follow up which will require
approximately 10-15 minutes extra time.
Standaardruiter 13
Veenendaal 3905 PT
NL
Standaardruiter 13
Veenendaal 3905 PT
NL
Listed location countries
Age
Inclusion criteria
- Patients are indicated for CRT*D implantation, as per current international certified guidelines
- Patients age is 18 years or greater
- Patients must indicate their understanding of the study and willingness to participate by signing
the appropriate informed consent form
- Patients must be willing and able to comply with all study requirements
Exclusion criteria
* Patients with a life expectancy <12 months.
* Patients who are or may potentially be pregnant.
* Patient has suffered any of the following in the 4 weeks prior to enrolment.
o MI
o CABG
o Unstable Angina Pectoris
* Patient has primary valvular disease which has not been corrected
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 | NL37815.098.11 |