Status:
TERMINATED
Unpinning Termination Therapy for VT/VF
Lead Sponsor:
Cardialen, Inc.
Collaborating Sponsors:
Genae
Five Corners
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators. This new method, called Unpinning Termination Therapy (UPT), is...
Detailed Description
A prospective single-arm feasibility study involving acute testing of UPT electrotherapy in subjects with VT/VF during clinically indicated ventricular tachycardia catheter ablation procedure or indic...
Eligibility Criteria
Inclusion
- Life expectancy of 1 year or greater
- Male or female between 18 and 75 years of age
- Willing and able to comply with the study protocol, provide a written informed consent
- Indication for an endocardial VT catheter ablation for sustained, life-threatening monomorphic VT OR an indication for VF and ICD implant (de novo implant, replacement or upgrade) OR CRT-D (de novo implant, upgrade from ICD) with transvenous leads for the risk of or presence of VT and/or VF.
- Etiology of arrhythmia, or risk of arrhythmia being ischemic dilated cardiomyopathy or non-ischemic idiopathic dilated cardiomyopathy both with LVEF ≤ 35% and meeting local standard of care
- Medically stable at time of consent to undergo DFT testing performed under general anesthesia or conscious sedation as determined by the investigator
Exclusion
- The subject must not meet any of the following exclusion criteria:
- Medically unstable at time of study and unsafe to undergo DFT testing under general anesthesia or conscious sedation as determined by the investigator
- Hemodynamic instability as determined by the investigator
- AF or atrial flutter for ≥ 48 hours or unknown duration, and no anticoagulation for preceding 3 weeks and no preoperative transesophageal echocardiographic confirmation of the absence of RA and LA thrombus
- AF or atrial flutter for \<48 hours and no Preoperative transesophageal echocardiographic confirmation of the absence of RA and LA thrombus
- Presence of intracardiac thrombus
- Inability to pass catheters to heart due to vascular limitations
- Cardiovascular anatomical defects that would complicate placement of the lead or catheter required by the protocol, including congenital heart disease and cardiac vein anomalies as determined by the investigator
- Pregnancy confirmed by test within 7 days of procedure
- Pacemaker dependent
- The presence of a normally functioning left ventricular lead which is not planned for revision
- Presence of ventricular assist device, including Intra-aortic balloon pump
- Subjects requiring the use of I.V. inotropes and/or vasopressors for hemodynamic support in the 14 days prior to the study
- Prior VT catheter ablation with associated serious complication, such as hemodynamic compromise despite pressor agents, stroke, cardiac perforation, AC fistula, pneumothorax, sepsis
- Incessant VT/VF or VT/VF storm
- LVEF \< 20%
- New York Heart Association (NYHA) Class IV heart failure
- Planned epicardial VT ablation on the same day as the research study
- History of hyper-coagulable state that could increase risk of thromboembolic events
- History of hemodynamic compromise due to valvular heart disease requiring IV inotropes or other circulatory support.
- Unstable coronary artery disease as determined by the investigator
- Severe proximal three-vessel or left main coronary artery disease, without revascularization as determined by the investigators
- History of embolic stroke, Transient Ischemic Attack or other thromboembolic event in the past 6 months
- History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis, Genetic Cardiac Channelopathy or Cardiac Sarcoidosis.
- Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure)
- Morbid obesity: BMI\>39 kg/m2
- Cognitive or mental health status that would interfere with study participation and proper informed consent
- Presence of mechanical tricuspid valve
- Active Endocarditis
- Ventricular arrhythmia etiology sarcoidosis
- Valvular ventricular tachycardia
- Previously implanted lead is under recall by manufacturer or evidence of lead failure as determined by the investigator
- End Stage Renal Disease on hemodialysis or peritoneal dialysis, or estimated glomerular filtration rate (eGFR) \<15 ml/min
- Right atrial or right ventricular lead implanted within 12 months prior to screening
- Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03871231
Start Date
July 17 2019
End Date
July 15 2021
Last Update
August 11 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
2
Gold Coast
Southport, Queensland, Australia, 4215
3
Royal Adelaide Hospital
Norwood, South Australia, Australia, 5067
4
Monash Medical
Clayton, Victoria, Australia, 3168