NCT02543632

PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE.

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
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: CardioKinetix, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Left Ventricular Dysfunction

Interventions

Type	Name	Description
DEVICE	Parachute Implant System	The CardioKinetix Parachute Implant partitions an enlarged ventricle into dynamic and static chambers. The static chamber is a portion of the left ventricular volume that is taken out of circulation. Stresses placed on the partitioned myocardium and the forces transmitted to the apical segment are decreased both in diastole and systole, eliminating the forces responsible for left ventricular dilation. In addition to this regional unloading, the reduction in size of the dynamic chamber results in a decrease of the myocardial stress in the normal myocardium via Laplace Law, providing a global unloading of the ventricle.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-09-07
• Last updated: 2017-06-22

Locations

10 sites across 1 country: Germany