Study purpose I: To evaluate and document appropriate clinical performance of the INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system and the INCEPTA cardiac resynchronization therapy ICD (CRT-D) system and associated application…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Purpose I:
For purpose I, the appropriate clinical performance will be assessed by
evaluating and documenting:
• Sensing, impedance and threshold tests per applicable Reference guide
• All adverse events and all Product Experiences
• VT/VF detection & conversion if performed at implant or pre-discharge
• Spontaneous episode conversion
• Wanded and wireless telemetry
Performance will be compared with historical data.
Secondary outcome
Purpose II:
Changes in mean Daily median respiratory rate (*RR) between event (11-7 days
before an index time) and baseline (60-56 days before an index time).
Background summary
Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate
Trend Evaluation in Heart Failure Patients
Study objective
Study purpose I:
To evaluate and document appropriate clinical performance of the INCEPTA (DR
and VR) implantable cardioverter defibrillator (ICD) system and the INCEPTA
cardiac resynchronization therapy ICD (CRT-D) system and associated application
software.
Study purpose II:
Demonstrate the clinical relevance of chronic ambulatory daily median
Respiratory Rate Trend (RRT) in HF patients
Study design
The study has two primary objectives, linked to the respective study purposes:
For purpose I:
The objective is to collect data on the performance of the INCEPTA ICD and
CRT-D devices during standard clinical use at implant, pre-discharge and at a
1-month post-implant device evaluation.
For purpose II:
The objective is to show that daily median respiratory rate increases more in
patients who experience an HF-event (Group 1) than in patients who do not
experience an HF-event (Group 2). A comparison will be made between patients
who experience an HF-event (Group 1) and patients who do not experience an
HF-event (Group 2).
Intervention
ICD/CRT-D implantation
Study burden and risks
Risks:
Patients participating in this study are subject to the same risks shared by
all patients undergoing implantation of an ICD or CRT-D system.
Benefits:
There may be no benefit to the patient.
Patients 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 patient 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
• Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical study;
• Patients whose age is 18 or above, or of legal age to give informed consent specific to national law
• Patients indicated for an ICD according to normal clinical practice (for those patients receiving an INCEPTA ICD).
o As soon as 20 ICD patients are included in the study for purpose I, only NYHA Class III patients will be allowed in the study*. NYHA class should be documented in the last 3 months.
• NYHA Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D). NYHA class should be documented in the last 3 months.
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.
• Inability or refusal to comply with the follow-up schedule
• Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
• Patients prescribed to positive airway pressure therapy
• A life expectancy of less than 1 year, per physician discretion
• Patient in NYHA Class IV during the last 4 weeks
• Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
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 | NL32450.068.10 |
| Other | wordt voor start studie geregistreerd bij www. clinicaltrials.gov |