Next Generation INCEPTA ICD and CRT-D Field Following Study (NOTICE-HF)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure Patients|
- 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. [ Time Frame: March2011 ] [ Designated as safety issue: No ]
- Show that daily median respiratory rate increases more in patients who experience an HF-event than in patients who do not experience an HF-event. [ Time Frame: Dec2011 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
INCEPTA ICD and CRT-D
ICD and CRT-D indicated patients
|Device: INCEPTA ICD or CRT-D|
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
- 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
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.
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.