Clinical study to collect chronic ambulatory data simultaneously from multiple sensors in CRT-D devices in order to develop algorithms for the early detection of worsening Heart Failure
- Conditions
- Health Condition 1: null- Heart Failure
- Registration Number
- CTRI/2012/05/002669
- Lead Sponsor
- Guidant Europe a Boston Scientific Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 990
1. Age 18 or above, or of legal age to give informed consent specific to state and national law.
2. Willing and capable of returning for all follow-up visits and emergency care at the investigational center as medically appropriate.
3. Willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center.
4. Currently implanted with a CRT-D system including a COGNIS device (model N119, N120, P107 or P108) with RA, RV and LV leads
5. Currently classified as NYHA Class II, III or IV within the last six months
1. Inability or refusal to sign the Subject Informed Consent.
2. Inability or refusal to comply with the follow-up schedule.
3. Documented as pacemaker dependent.
4. Unable to rest comfortably in a semi-recumbent position for up to 20 minutes.
5. Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949.
6. Currently implanted with unipolar RA, RV, or LV leads.
7. LV sensitivity programmed to less than 0.7 mV AGC.
8. Subjects that have a history of appropriate Tachycardia Therapy (external or implanted) for rates 165 bpm within 1 week prior to enrollment.
9. Device battery status indicates approximate time to explant 2 years.
10. Likely to undergo lead or PG revision during the course of the study as determined by the investigator.
11. Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen.
12. Subjects that have received a heart or lung transplant.
13. Receiving mechanical circulatory support.
14. Subjects who have been referred or admitted for Hospice care.
15. A life expectancy of less than 12 months per physician discretion.
16. Enrolled in any concurrent study without Boston Scientific written approval.
17. Subjects whose devices have previously been converted to the SRD-1 and withdrawn from this study.
18. Subjects who have received a sub-pectoral COGNIS implant prior to February 1st 2011 that has a dash number listed in APPENDIX K.
19. Women who are known to be pregnant or plan to become pregnant within the course of the study.
20. LV offset is programmed to a value greater than zero
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Heart Failure Events <br/ ><br> <br/ ><br>The primary objectives of this study are to determine how ambulatory sensor measurements change with worsening heart failure, and to develop multisensor detection algorithms. There are no formal statistical primary or secondary endpoints defined for this study.Timepoint: 12 Month
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil