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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 7 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Treatment Group Single Arm Group to receive ablation.
  • Device: FlexAbility SE Ablation Catheter
    Subjects receive ablation treatment.

Recruiting Locations

Memorial Hermann Hospital
Houston, Texas 77030
Contact:
Mary Pierce

More Details

Status
Recruiting
Sponsor
Abbott Medical Devices

Study Contact

George Galoussian
8182945677
george.galoussian@abbott.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.