ext Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure Patients NOTICE-HF

Phase 4

Completed

Conditions: 10007521
Ventricular Tachyarrhythmia's - cardiac rythm disorder

Registration Number: NL-OMON34143

Lead Sponsor: Boston Scientific

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Purpose I:<br /><br>For purpose I, the appropriate clinical performance will be assessed by<br /><br>evaluating and documenting:<br /><br>• Sensing, impedance and threshold tests per applicable Reference guide<br /><br>• All adverse events and all Product Experiences<br /><br>• VT/VF detection & conversion if performed at implant or pre-discharge<br /><br>• Spontaneous episode conversion<br /><br>• Wanded and wireless telemetry<br /><br>Performance will be compared with historical data.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Purpose II:<br /><br>Changes in mean Daily median respiratory rate (*RR) between event (11-7 days<br /><br>before an index time) and baseline (60-56 days before an index time).</p><br>