Abbott Ventricular Tachycardia PAS

Launched by ABBOTT MEDICAL DEVICES · Apr 21, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Abbott Ventricular Tachycardia PAS, is studying the long-term safety and effectiveness of a special device called the FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE). This device is used to treat a serious heart condition known as ventricular tachycardia, which is when the heart beats too fast and can lead to complications. The study is currently recruiting participants who have tried other medications without success and have a specific type of heart disease. To be eligible, participants need to give their consent, have recurrent ventricular tachycardia, and must already have a device implanted in their heart, like a defibrillator.

If someone decides to take part in this study, they will be part of an observational study, which means that researchers will monitor their progress and gather information about their health over time. Participants will need to follow the study requirements and attend regular check-ups. It's important to note that certain health conditions, like active infections or specific heart surgery in the last month, may prevent someone from joining. Overall, the goal of this trial is to gather important information that can help improve treatments for people with this heart condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure
• • 2. Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemic structural heart disease and a clinical decision has been made to use FlexAbility SE for an ablation procedure prior to enrollment in the research study
• • 3. Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT
• • 4. Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
• • 5. Able and willing to comply with all study requirements
• Exclusion Criteria:
• • 1. Documented or known intracardiac thrombus or myxoma
• • 2. Active systemic infection
• • 3. History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure
• • 4. Patients with prosthetic valves as the catheter may damage the prosthesis
• • 5. Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation