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Long-term safety and effectiveness of FlexAbility Ablation Catheter for ventricular tachycardia

Abbott Ventricular Tachycardia Post Approval Study

Observational Abbott Medical Devices · NCT05839873

This study is testing how safe and effective the FlexAbility Ablation Catheter is for treating people with recurring ventricular tachycardia who haven't found relief from medications.

Quick facts

Study typeObservational
Enrollment150 (estimated)
Ages7 Years and up
SexAll
SponsorAbbott Medical Devices Industry-sponsored
Locations14 sites (Aurora, Colorado and 13 other locations)
Trial IDNCT05839873 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather ongoing clinical evidence regarding the long-term safety and effectiveness of the FlexAbility Ablation Catheter in treating ventricular tachycardia. It is a prospective, single-arm, open-label, multi-center study that includes patients who have recurrent, drug-refractory sustained monomorphic ventricular tachycardia and have made a clinical decision to undergo ablation. Participants will be monitored for outcomes related to the catheter's performance in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with recurrent, drug-refractory sustained monomorphic ventricular tachycardia and non-ischemic structural heart disease who are scheduled for ablation.

Not a fit: Patients with documented intracardiac thrombus, active systemic infections, or recent heart surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of a new treatment option for patients with ventricular tachycardia.

How similar studies have performed: Other studies have shown promising results with similar ablation techniques, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Aurora, Colorado and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ventricular Tachycardia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.