To gather data to support global submissions/approvals for some models of the Ingenio device family.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effectiveness:
Right Atrial Automatic Threshold
1. Manual Unipolar vs. Commanded: Demonstrate the clinical equivalence of the
commanded thresholds determined by the RAAT algorithm and the thresholds
determined by the manual unipolar threshold tests.
2. Manual Unipolar vs. Ambulatory: Demonstrate the clinical equivalence of the
ambulatory thresholds determined by the RAAT algorithm and the thresholds
determined by the in-clinic manual unipolar threshold tests.
3. Appropriate Commanded RAAT Outcome: Demonstrate that the commanded RAAT
threshold tests produce appropriate outcomes.
RYTHMIQ
4. Demonstrate a relative reduction of RV pacing with RYTHMIQ ON versus RYTHMIQ
OFF.
Safety:
System-related complications (for FDA submission purposes)
5. Evaluate and document the System-related complications by assessing the
SRCFR (without LV related events for CRT-P patients)
RAAT output margin
6. Demonstrate that the commanded RAAT threshold test produces a sufficient
pacing voltage output.
Safety parameters:
1. System-related complications
2. Percentage of RAAT tests resulting in a sufficient pacing output
Effectiveness parameters:
1. RAAT commanded test: Percentage of tests resulting in
a) an accurately-determined threshold
b) an appropriate test outcome
2. RAAT ambulatory tests: Percentage of tests resulting an
accurately-determined threshold
3. RYTHMIQ: % reduction in RV pacing (compared to RYTHMIQ OFF)
Secondary outcome
Not applicable
Background summary
Bradycardia therapy by means of implantable pacemakers is a well-established
procedure for over 50 years. Worldwide the number of implants of pacemakers is
steadily increasing. For outpatient clinics this poses an incremental burden.
Therefore device manufacturers have developed automatic algorithms to lighten
this workload, like automatic capture for the ventricle. Subsequently research
has been performed to introduce an automatic capture feature for the atrial
channel and it was also introduced into clinical practice.
A high percentage of right ventricular stimulation can lead to a worsening of
left ventricular function. Therefore avoiding needless right ventricular
stimulation in patients with sufficient underlying ventricular activity seems
beneficial and new pacemaker algorithms support this goal.
HF patient management aiming at preventing hospitalizations could have
significant impact on patient care and economics. Given that an ever increasing
number of HF patients have an implanted device, a potential exists for even
greater benefits if the implanted device can be used to recognize signs of
worsening HF since the implanted device has continuous access to the patient.
Study objective
To gather data to support global submissions/approvals for some models of the
Ingenio device family.
Study design
Prospective, multi-center, randomized within-patient, single-blinded study
Intervention
Pacemaker/CRT-P implantation
Study burden and risks
Risks:
Subjects participating in this study are subject to the same risks shared by
all patients undergoing implantation of a pacemaker or CRT-P system. Additional
risks may exist.
Benefits:
There may be no benefit to the subject.
Subjects enrolled in this clinical evaluation may have some benefit from
receiving the latest device technology since features within the implanted
devices may provide some clinical benefit over existing models and
technologies. The subject may also benefit from closer device follow-up due to
the clinical protocol schedule.
Lambroekstraat 5D
1831 Diegem
BE
Lambroekstraat 5D
1831 Diegem
BE
Listed location countries
Age
Inclusion criteria
Subjects who are willing and capable of providing informed consent to undergo a device implant and to participate in all testing associated with this clinical study;;Subjects whose age is 18 or above.;Subjects indicated for a dual chamber pacemaker or a CRT-P device according to class I or class II indications of the standard ESC or ACC / AHA implant guidelines;;Subjects who are planned to be implanted with all leads intended for a specific device type (dual chamber pacemaker: atrial and right ventricular lead, CRT-P: atrial, right and left ventricular lead) or are already implanted with such leads;;Subjects who receive or are implanted with a bipolar atrial lead.
Exclusion criteria
Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician*s discretion);;Enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict or affect
* Schedule of procedures for IVORY (i.e. should not cause additional or missed visits);
* Programming of devices for IVORY per CIP;
* IVORY outcome (i.e. involve medications, that could affect the heart rate of the subject);
* Conduct of IVORY per GCP / ISO 14 155:2011 / local regulations;;Subject who live at such a distance from the clinic that travels for follow-up visits would be unusually difficult or burdensome for the subject;;Inability or refusal to comply with the follow-up schedule;;A life expectancy of less than 12 months, per physician discretion;;Subjects who are planned to be programmed to a pacing mode other than DDD / DDDR during the study period.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| ClinicalTrials.gov | NCT01441583 |
| CCMO | NL37760.098.11 |