Percutaneous Ventricular Restoration in Chronic Heart Failure due to Ischemic Heart Disease

Percutaneous Ventricular Restoration in Chronic Heart Failure due to Ischemic Heart Disease - PARACHUTE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36701

Enrollment

Registered

2011-11-02

Start date

2011-12-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

apical aneurysm chronic heart failure

Interventions

Percutaneous implantation of a Parachute in the left ventricle in patients with chronic heart faillure and due to ischemic heart dissease.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Akinesis or dyskinesis due to previous myocardial infarction limited to anteroapical region. Patient is not hospitalized at time of enrollment. Diagnosis of heart failure for a minimum of 6 months prior to enrollment NYHA Class III or IV . Post LV myocardial infarction structural heart dysfunction represented by LV wall motion abnormality by echocardiography. LVEF >15% and * 40% as measured by echocardiography. Between 18 and 79 years of age. Receiving appropriate medical treatment for heart failure.

Exclusion criteria

Exclusion criteria: Untreated clinically significant coronary artery disease requiring intervention. Acute myocardial infarction or revascularization procedure (PCI or CABG) within 60 days of enrollment. Cardiogenic shock within 72 hours of enrollment. Contraindication for asparin and anticoagulation therapy. Moderate aortic stenosis and regurgitation >2+. Aortic valve replacement or repair.

Design outcomes

Primary

Measure	Time frame
Assessment of safety defined as the successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device.	—

Secondary

Measure	Time frame
Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months. Change in exercise tolerance from baseline to 6 and 12 month follow-up as measured by 6-Minute Walk Test. Combined cardiovascular mortality and morbidity that includes all cause death, hospitalization for heart failure, myocardial infarction and stroke from baseline to 6, and 12 months.	—

Measure

Time frame

Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months. Change in exercise tolerance from baseline to 6 and 12 month follow-up as measured by 6-Minute Walk Test. Combined cardiovascular mortality and morbidity that includes all cause death, hospitalization for heart failure, myocardial infarction and stroke from baseline to 6, and 12 months.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)