Abbott Ventricular Tachycardia PAS

Recruiting at 12 trial locations

Overseen By Ben Gansemer, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to confirm the safety and effectiveness of the FlexAbility SE catheter for treating ventricular tachycardia. The device works by creating small scars in the heart to block abnormal electrical signals, helping to restore a normal heart rhythm. The study focuses on patients with this serious heart condition who may not respond well to other treatments. Catheter ablation has emerged as an important and effective treatment option for many recurrent ventricular arrhythmias.

Research Team

Kristin Ruffner, PhD

Principal Investigator

Clinical Program Director

Eligibility Criteria

Inclusion Criteria

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

Treatment Details

Interventions

• FlexAbility SE Ablation Catheter

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Single Arm Group to receive ablation.

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business