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Active, Not Recruiting

NCT Number: NCT05839873

Abbott Ventricular Tachycardia PAS

This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NCH Healthcare System, Naples, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure
  • 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
  • Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT
  • Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
  • Able and willing to comply with all study requirements

Exclusion criteria

  • Documented or known intracardiac thrombus or myxoma
  • Active systemic infection
  • History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure
  • Patients with prosthetic valves as the catheter may damage the prosthesis
  • Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation

Treatment and study plan

FlexAbility SE Ablation Catheter

Device

Subjects receive ablation treatment.

Primary outcomes

  1. Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.

    Time frame: 12 Month

  2. Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation

    Time frame: 12 Month

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Abbott Ventricular Tachycardia Post Approval Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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