Clinical trial NCT05839873: Abbott Ventricular Tachycardia PAS
Official title: Abbott Ventricular Tachycardia Post Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Tachycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 150
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical investigation will enroll subjects of all genders who have recurrent, drug-refractory, sustained monomorphic ventricular tachycardia in patients with non-ischemic structural heart disease.

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.


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

Primary outcomes:
measure: Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.
timeFrame: 12 Month
measure: Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation
timeFrame: 12 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Naples
country: United States
facility: NCH Healthcare System
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research Foundation
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: VA Medical Center Minneapolis
state: Minnesota
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Heart & Vascular Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Heart & Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: Clinical Program Director
name: Kristin Ruffner, PhD
role: STUDY_DIRECTOR
References: