Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation (PERMIT1)
|ClinicalTrials.gov Identifier: NCT01294267|
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment|
|Ventricular Tachycardia||Device: Circulatory Support System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||PERcutaneous heModynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation|
|Study Start Date :||September 2010|
|Primary Completion Date :||August 2011|
|Study Completion Date :||January 2012|
U.S. FDA Resources
Circulatory Support System
Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.
Device: Circulatory Support System
Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects
Other Name: Impella 2.5 Circulatory Support system insertion
- Number of Participants With Procedural Success [ Time Frame: Inpatient Admission ]Satisfactory hemodynamic status during the ablation procedure [during VT Mapping and Ablation Procedure], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System
- Clinical Outcomes [ Time Frame: 1 Month post ablation Follow up ]Morbidity and Mortality, as determined by clinical metrics and validated by tests during and immediately post VT Mapping and ablation procedure with cardiac monitoring in hospital and one Month [30 days] follow up telephone interview to assess symptoms, side effects and medication use.
- Safety Outcomes [ Time Frame: 30 day ]
Acute Kidney Injury Network stage 1 kidney injury (ie, an absolute increase in serum creatinine of ≥0.3 mg/dL or percentage increase of 150%-200% from baseline.
A decline in neurocognitive function, as defined by a decrease in MMSE ≥2 points from the baseline score, after the procedure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294267
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Vivek Reddy, MD||Icahn School of Medicine at Mount Sinai|