Ventricular Tachycardia
Conditions
Keywords
Ventricular Tachycardia, Radio Frequency Ablation, Percutaneous Left Ventricular Assist Device, Hemodynamic Management, Interventional Cardiac Procedure, Mechanical Cardiac Assistance, Intra-Aortic Balloon Pump, Coronary Intervention, Impella 2.5, Circulation Support system
Brief summary
The purpose of this research study is to evaluate the safety and feasibility of the Impella 2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia in the setting of Ventricular dysfunction.
Detailed description
The Impella 2.5 is a percutaneous heart pump that will be used to provide partial circulatory support -. The Impella 2.5 is approved by the US Food and Drug Administration and is being tested to see if it helps keep the patient's blood pressure stable during the cardiac ablation procedure. The Impella 2.5 Circulatory Support System works by placing a small pump into the left pumping chamber of the heart which will then help the heart circulate blood throughout the body. The Impella 2.5 Circulatory Support system will be removed once the heart no longer needs help with the pumping action which can be at any time from just after the completion of the heart procedure up to several days post procedure as determined by physician.
Interventions
DEVICECirculatory 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
Sponsors
Abiomed Inc.
Vivek Reddy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* male or female * age 18 to 90 years * catheter ablation of ventricular tachycardia * Left Ventricular ejection fraction less than or equal to 40% or hypertrophic cardiomyopathy
Exclusion criteria
* Any reversible cause of VT \[electrolyte derangements, medication related itc\] * Evidence of active, ongoing cardiac ischemia as the cause of VT * Patients who have experienced any cerebral ischemic event including any TIA in the preceding one month * Mural thrombus in left Ventricle * Presence of mechanical aortic valve * Severe Aortic Stenosis \[orifice area of 2.0 cm2 or less\] or moderate to severe aortic insufficiency * Severe abnormalities of the aorta that would preclude Impella insertion, including aneurysms and extreme tortuosity or calcifications * Liver dysfunction or markedly abnormal coagulation parameters \[as defined by platelet count less than or equal to 50,000/ul\] * Any condition resulting in contraindication to anticoagulation \[eg GI bleeding\] * Women who are known to be pregnant or have had a positive B-HCG test 7 days prior to procedure * Patients whose life expectancy is less than one year * Mental Impairment precluding patient or family from providing informed consent or completing the appropriate follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcomes | 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. |
Countries
United States
Participant flow
Recruitment details
Twenty consecutive patients with scar VT underwent ablation between Sept 2010 and July 2011.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Circulatory Support System |
|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 11.6 |
| Chronic Kidney Disease | 6 Participants |
| Diabetes Mellitus | 6 Participants |
| Hypertension | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 20 |
| other Total, other adverse events | 3 / 20 |
| serious Total, serious adverse events | 5 / 20 |
Outcome results
Primary
Number of Participants With Procedural Success
Satisfactory hemodynamic status during the ablation procedure \[during VT Mapping and Ablation Procedure\], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System
Time frame: Inpatient Admission
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulatory Support System | Number of Participants With Procedural Success | Complete procedural sucess | 8 Participants |
| Circulatory Support System | Number of Participants With Procedural Success | Partial procedural sucess | 6 Participants |
Secondary
Clinical Outcomes
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.
Time frame: 1 Month post ablation Follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulatory Support System | Clinical Outcomes | Death from any cause | 2 Participants |
| Circulatory Support System | Clinical Outcomes | Hospitalization for any cause | 5 Participants |
| Circulatory Support System | Clinical Outcomes | Sustained VT/ICD therapy | 4 Participants |
Other Pre-specified
Safety Outcomes
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.
Time frame: 30 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulatory Support System | Safety Outcomes | Acute kidney injury stage 1 | 3 Participants |
| Circulatory Support System | Safety Outcomes | Postop cognitive dysfunction | 1 Participants |