Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT02543632
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:
NCT02543632
Study Brief:
Protocol Section:
NCT02543632