Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-02 @ 4:55 AM
Study NCT ID:
NCT02543632
Status:
TERMINATED
Last Update Posted:
2017-06-22
First Post:
2015-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE.
Sponsor:
CardioKinetix, Inc
Organization:
Study Overview
Official Title:
PARACHUTE V: PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE. A German Trial to Evaluate the Improvement in Quality of Life and Cardiac Output Following Implanting of the Parachute Implant System
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P5
Brief Summary:
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.
Detailed Description:
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the European Conformity Approved (CE marked) CardioKinetix Parachute Implant System. The primary objective is to establish quality-of-life and cardiac output benefit of the Parachute Implant of patients presenting with symptoms of heart failure due to ischemic heart disease. A maximum of 105 treated patients and approximately 25 control patients may be enrolled, with a maximum of 25 treated patients enrolled from any one center. The Primary Endpoint is an improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline using the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The Secondary Endpoint is an improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: