Abbott Ventricular Tachycardia PAS

Abbott Ventricular Tachycardia Post Approval Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05839873

Enrollment

Registered

2023-05-03

Start date

2023-07-24

Completion date

2026-11-30

Last updated

2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Tachycardia

Brief summary

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.

Interventions

DEVICEFlexAbility SE Ablation Catheter

Subjects receive ablation treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.	12 Month
Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation	12 Month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026