Abbott Ventricular Tachycardia PAS

Ventricular Tachycardia Clinical Trial

Official title:

Abbott Ventricular Tachycardia Post Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839873
• Other study ID #: ABT-CIP-10471
• Status: Recruiting
• Start date: July 24, 2023
• Est. completion date: November 2028

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: George Galoussian
• Phone: 8182945677
• Email: george.galoussian[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• FlexAbility SE Ablation Catheter
Subjects receive ablation treatment.

Locations

Country	Name	City	State
United States	Aurora Denver Cardiology Associates	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Baylor Scott & White Heart & Vascular Hospital	Dallas	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	VA Medical Center Minneapolis	Minneapolis	Minnesota
United States	NCH Healthcare System	Naples	Florida
United States	Vanderbilt Heart & Vascular Institute	Nashville	Tennessee
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Sarasota Memorial Hospital	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

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