PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE. (P5)
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|ClinicalTrials.gov Identifier: NCT02543632|
Recruitment Status : Terminated (Company closed)
First Posted : September 7, 2015
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment|
|Heart Failure Left Ventricular Dysfunction||Device: Parachute Implant System|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||85 participants|
|Target Follow-Up Duration:||6 Months|
|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|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Subjects who meet the inclusion/exclusion criteria listed and also are approved via anatomical inclusion criteria for treatment with the Parachute Implant System.
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.
Other Name: Parachute Device
Subjects who meet the inclusion/exclusion criteria listed and also are are excluded for treatment with the Parachute Implant System due to anatomical characteristics such as obstructing pseudochordae, calcification, or wall thickness.
- Quality of Life [ Time Frame: 6 months ]An improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline (day -1) using the Minnesota Living with Heart Failure (MLWHF) Questionnaire.
- Stroke Volume Index [ Time Frame: 0 days (at implant) ]An improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543632
|Cardiac Research GmbH|
|Dortmund, Hohe Straße 1, Germany, Dortmund|
|Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie|
|Essen, Klara-Kopp-Weg 1, Germany, 45138|
|Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie|
|Düsseldorf, Moorenstr. 5, Germany, 40225|
|Aachen, Germany, 52074|
|Bad Nauheim, Germany, 61231|
|Cologne, Germany, 50937|
|Erlangen, Germany, 91054|
|Asklepios Klinik St. George|
|Hamburg, Germany, 20099|
|Universitäres Herzzentrum Hamburg Eppendorf GmbH|
|Hamburg, Germany, 20251|
|Principal Investigator:||Helge Möllmann, MD||Kerckhoff Klinik|