Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study

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

This study has 2 purposes:

The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these new devices work in patients. This new family is called the INCEPTA ICD and the INCEPTA CRT-D.

The second purpose of the study is to collect data from a feature that monitors breathing. It is called the Respiratory Rate Trend (RRT). These data will help to better understand how changes in breathing relate to changes in clinical conditions.

Study Purpose

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 Device

• INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system (Models F160, F161, F162, F163)
• INCEPTA cardiac resynchronization therapy ICD (CRT-D) system (Models P162, P163, P165)

Indication ICD / CRT-D Indication according to standard clinical practice

Study Objectives

The study has two primary objectives, linked to the respective study purposes:

For purpose I:

The objective is to collect data on the clinical performance of the INCEPTA ICD and CRT-D devices during standard clinical use at implant, pre-discharge and at a 1-month post-implant. Clinical performance included analysis of pacing thresholds, pacing impedance, sensing thresholds, number of successfully converted VT/VF episodes, induced episodes detection times, spontaneous episodes, wanded telemetry, adverse events (AEs) and product experiences.

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).

This is a prospective, multi-centre, field following study.

Up to 35 study centers in the International geography will enrol 120 patients.

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).

  -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.

• New York Heart Association (NYHA) Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D).

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