Trial Outcomes & Findings for Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation (NCT NCT01294267)

NCT ID: NCT01294267

Last Updated: 2018-02-14

Results Overview

Satisfactory hemodynamic status during the ablation procedure \[during VT Mapping and Ablation Procedure\], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Inpatient Admission
• Results posted on: 2018-02-14

Participant Flow

Twenty consecutive patients with scar VT underwent ablation between Sept 2010 and July 2011.

Participant milestones

Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation

Baseline characteristics by cohort

Measure	Circulatory Support System n=20 Participants 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.
Age, Continuous	58.5 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Hypertension	14 Participants n=5 Participants
Chronic Kidney Disease	6 Participants n=5 Participants
Diabetes Mellitus	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Circulatory Support System n=20 Participants 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. 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
Number of Participants With Procedural Success Partial procedural sucess	6 Participants
Number of Participants With Procedural Success Complete procedural sucess	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Circulatory Support System n=20 Participants 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. 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
Clinical Outcomes Death from any cause	2 Participants
Clinical Outcomes Hospitalization for any cause	5 Participants
Clinical Outcomes Sustained VT/ICD therapy	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Circulatory Support System n=20 Participants 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. 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
Safety Outcomes Acute kidney injury stage 1	3 Participants
Safety Outcomes Postop cognitive dysfunction	1 Participants

Adverse Events

Circulatory Support System

Serious events: 5 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Measure	Circulatory Support System n=20 participants at risk 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.
Cardiac disorders Death	10.0% 2/20 • Number of events 2
General disorders Hospitalization	25.0% 5/20 • Number of events 5

Other adverse events

Measure	Circulatory Support System n=20 participants at risk 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.
Renal and urinary disorders Acute Kidney Injury	15.0% 3/20 • Number of events 20

Additional Information

Vivek Y. Reddy, MD

Icahn School of Medicine at Mount Sinai, Helmsley Electrophysiology Center

Phone: 212-241-7114

Email: vivek.reddy@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place