Cryoablation for Monomorphic Ventricular Tachycardia

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

IC 1 Male or female the ages of >= 18 years
IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic
recurrent symptomatic sustained monomorphic Ventricular Tachycardia also
defined as having a similar QRS configuration from beat to beat.
IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure.
IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able
to treat the arrhythmia satisfactorily or induces unwanted side effects).
IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the
previous 3 months or during baseline evaluation
IC 6 Willingness, ability, and commitment to participate in baseline and
follow-up evaluations for the full length of the study
IC 7 Willingness and ability to give an informed consent

Exclusion Criteria

EC 1 Any known objective contraindication to ventricular tachycardia ablation,
TEE, or anticoagulation, including but not limited to the identification of any
cardiac thrombus or evidence of sepsis
EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular
tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT
is not.
EC 3 Any VT ablation within 4 weeks prior to enrollment
EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior
surgical treatment for ventricular tachycardia
EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid
disease, or any other reversible or non-cardiac cause
EC 6 Structural heart disease as described below:
a. Class IV heart failure
b. Aortic aneurysm
c. Previous cardiac surgery or percutaneous coronary intervention within 60
days prior to the procedure
d. Interatrial baffle, closure device, patch, or PFO occlusion device
e. IVC filter
f. Coronary artery bypass graft (CABG) procedure within six (6) months prior
to the ablation procedure
g. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
h. Cardiac myxoma
i. Significant congenital anomaly
j. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to
the ablation procedure
k. Mechanical aortic or mitral valve
EC 7 Any previous history of cryoglobulinemia
EC 8 History of blood clotting or bleeding disease
EC 9 Any prior history of documented cerebral vascular accident (CVA), TIA or
systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT),
within 6 months prior to the ablation procedure.
EC 10 Breastfeeding, pregnant, or anticipated pregnancy during study follow-up
EC 11 Current enrollment in any other study protocol where testing or results
from that study may interfere with the procedure or outcome measurements for
this study
EC 12 Any other condition that, in the judgment of the investigator, makes the
patient a poor candidate for this procedure, the study or compliance with the
protocol (includes vulnerable patient population, mental illness, addictive
disease, candidate for heart transplantation, patient with ventricular assist
device, or terminal illness with a life expectancy less than 12 months)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Primary Endpoint for Safety is an analysis of the proportion of subjects<br /><br>who are free from definite or probable device/procedure related Major Adverse<br /><br>Events (MAEs) that occur during or within 30 days following the cryoablation<br /><br>procedure.<br /><br><br /><br>The Primary Endpoint for Clinical Performance is an analysis of the proportion<br /><br>of patients receiving a single cryoablation procedure with freedom from<br /><br>ventricular tachycardia lasting longer than 30 seconds or appropriate ICD<br /><br>intervention until the end of the 6 month follow up period.<br /><br><br /><br>The Primary Endpoint for Procedure Performance is an analysis of the proportion<br /><br>of subjects with non-inducible clinical monomorphic VT at the conclusion of the<br /><br>initial cryoablation procedure.</p><br>

Secondary Outcome Measures