Unpinning Termination Therapy for VT/VF
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03871231|
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia Ventricular Fibrillation||Device: Unpinning Termination Therapy||Not Applicable|
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 indicated implantable cardioverter defibrillator implant, upgrade, or replacement or new CRT-D implant or upgrade to CRT-D.
The study involves up to two roll in subjects at each participating site followed by an UPT evaluation and refinement segment in which remaining subjects are enrolled until arrhythmia terminations from UPT delivery are reliably achieved. A prospective evaluation segment will be performed to compare UPT against SBS and ATP if sufficient subjects remain once reliable terminations from UPT are achieved.
Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Non-randomized, non-blinded, prospective, single-arm, acute, early-feasibility study|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||An International Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT/VF|
|Actual Study Start Date :||July 17, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Unpinning Termination Therapy Arm
Subjects will have VT/VF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia
Device: Unpinning Termination Therapy
The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen Unpinning Therapy (UPT) therapy. The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.
- Safety of UPT therapy [ Time Frame: Study procedure and 30 day post procedure ]Adverse events
- Safety of UPT therapy [ Time Frame: 30 day post procedure ]Adverse events
- Parameters at which UPT terminates VT and VF [ Time Frame: Study procedure ]Voltage
- Voltage at which UPT and endocardial single biphasic shock terminate VT/VF [ Time Frame: Study procedure ]Voltage
- Voltage at which UPT and ATP terminate VT [ Time Frame: Study procedure ]Voltage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871231
|Contact: Dave Munneke, MS||6128049516||DMunneke@cardialen.com|
|Contact: Thomas Rasmussen, BAfirstname.lastname@example.org|
|The Prince Charles Hospital||Recruiting|
|Chermside, Queensland, Australia, 4032|
|Contact: Maricel Roxas, RN +61 7 3139 5906 email@example.com|
|Contact: Megan Mearns, RN +61 7 3139 4711 firstname.lastname@example.org|
|Principal Investigator:||Harris Haqqani, MD||The Prince Charles Hospital|