NCT05839873

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2023Nov 2026

First Submitted

Initial submission to the registry

April 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

April 21, 2023

Last Update Submit

October 15, 2025

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Treatment Group

Single Arm Group to receive ablation.

Device: FlexAbility SE Ablation Catheter

Interventions

FlexAbility SE Ablation CatheterDEVICE

Subjects receive ablation treatment.

Treatment Group

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

NCH Healthcare System

Naples, Florida, 34102, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46240-0970, United States

Location

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

VA Medical Center Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Baylor Scott & White Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kristin Ruffner, PhD

    Clinical Program Director

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

July 24, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(11)