The purpose of this study is to evaluate and document that the clinical performance of the TELIGEN 100 HE and COGNIS 100 HE systems and associated application software is within design specifications. It will also document the appropriate clinical…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Device Specific Objectives of this study are to evaluate performance of all
TELIGEN and COGNIS 100 HE devices as shown by documenting appropriate detection
and shock conversion of induced ventricular tachyarrhythmia*s (VT/VF) at
implant and/or pre-discharge. The RMS-Specific Objectives of this study are to
evaluate appropriate performance of the Reverse Mode Switch (RMS) feature by
documenting a 1-month RMS related Adverse-Event-Free-rate in TELIGEN 100 HE DR
patients with the feature ON. And also to evaluate appropriate performance of
the Reverse Mode Switch (RMS) feature by documenting a reduction in right
ventricular pacing (Vp) with the feature ON versus OFF between the 1-month and
3-month visit. The Lead- Specific Objective of this study is to evaluate
appropriate performance of the RELIANCE 4-SITE defibrillation lead by
demonstrating appropriate pacing thresholds at follow-up.
Secondary outcome
To evaluate the performance of the Quick Convert ATP feature during normal
clinical operation, to collect the number and appropriate function of Reverse
Mode Switches during normal clinical operation, to collect and report
percentage of BiV pacing in COGNIS 100 HE patients, to collect and report
Respiration Rate Trend data, if available and to collect and report all adverse
events including specifically all 4-SITE lead-related Adverse Events.
Background summary
The purpose of the study is to test a new family of Boston Scientific
Implantable Cardioverter Defibrillators (*ICDs*) called the TELIGEN 100 HE ICD
and the COGNIS 100 HE CRT-D. For some patients receiving the TELIGEN 100 HE
ICD, there may also be a test of a new feature called *Reverse Mode Switch*.
This new function is designed to safely limit the amount of pacing pulses that
are sent to the right side of your heart so that it only provides pacing when
you really need it. If available during the course of the study, a new type of
lead called the RELIANCE 4-SITE lead will also be tested because it only has
one pin to attach it to the device rather than the 3 pins used with older
leads.
Study objective
The purpose of this study is to evaluate and document that the clinical
performance of the TELIGEN 100 HE and COGNIS 100 HE systems and associated
application software is within design specifications. It will also document the
appropriate clinical performance of the 4-SITE defibrillation lead and
associated quadripolar header configuration (if available within the timeline
of the study). Moreover, the optional RMS sub-study will evaluate the clinical
performance of the RMS feature in the TELIGEN 100 HE DR ICD.
Study design
This is a prospective and multi-centre study with data collected from a maximum
of 450 patients at up to 50 study centres worldwide. The study consists of
three patient groups. 1) For the device-related objectives are needed 150
patients at a minimum. 2) For the RMS sub-study are needed 110 patients at a
minimum. 3) For the 4 SITE lead objectives are needed 150 patients at a
minimum. Patients can participate to either one or more groups, so group 1)
and/or 2) and /or 3). For group 1) and 2) there are two additional visits,
namely at 1 and 3 months. Patients who participate to group 2) will have the
RMS function from implantation till the 1 month visit, during which
randomisation will determine whether the function will be on or off till the
visit at month 3. Patients who only participate to group 3) will be followed by
standard practice.
Study burden and risks
Burden : patients in group 1) and / or 2) require an additional visit at month
1 and 3.
Risk : the risks related to study participation are the same as when the
patient would not participate to the study.
Lambroekstraat 5D
1831 Diegem
Belgium
Lambroekstraat 5D
1831 Diegem
Belgium
Listed location countries
Age
Inclusion criteria
Inclusion Criteria TELIGEN and COGNIS 100 HE:
• ICD Indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE)
• CRT-D Indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE)
• Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
• Geographically stable patients who are available for follow-up at a study centre.
• Age 18 or above, or of legal age to give informed consent specific to national law
Reverse Mode Switch Sub-Study:
• Meet general inclusion/exclusion criteria for COGENT-4 study
• Implanted with TELIGEN 100 HE DR
Exclusion criteria
Exclusion Criteria TELIGEN and COGNIS 100 HE
• Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
• Patients currently requiring dialysis
• Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion
• Enrolled in any concurrent study
• Patients implanted with the following leads which will not be abandoned:
- Atrial or right ventricular unipolar leads
- Patch defibrillation leads
- Non-compatible defibrillation leads (e.g. 5/6mm)
Reverse Mode Switch Sub-Study:
• Documented permanent/Complete AV block
• Documented permanent atrial fibrillation (AF)
Design
Recruitment
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 | NL20173.058.07 |