FlexAbility SE Ablation Catheter for Ventricular Tachycardia

Not currently recruiting at 10 trial locations

Overseen By Ben Gansemer, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must be taking: Class I/III anti-arrhythmics

Disqualifiers: Intracardiac thrombus, Systemic infection, Prosthetic valves, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term safety and effectiveness of the FlexAbility SE Ablation Catheter, a device that treats ventricular tachycardia—a condition where the heart beats very fast due to electrical problems. The trial aims to confirm the device's effectiveness in real-world settings following its approval for use. Individuals experiencing ongoing, hard-to-treat episodes of fast heartbeats that do not respond to medication, and who have a specific heart implant, may be suitable candidates for this study. As a Phase 4 trial, the study focuses on understanding how the FDA-approved device benefits more patients in everyday settings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have tried and found at least one Class I/III anti-arrhythmic medication ineffective, not tolerated, or not desired.

What is the safety track record for the FlexAbility SE Ablation Catheter?

Research has shown that the FlexAbility SE Ablation Catheter is safe for treating heart rhythm issues such as ventricular tachycardia. Previous studies support its strong safety record. Patients typically tolerate the treatment well, with few serious side effects reported. The FDA has already approved the catheter for similar uses, indicating it meets strict safety standards. Overall, the treatment's safety profile is reassuring, making it a good option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the FlexAbility SE Ablation Catheter because it offers a more precise and flexible approach to treating ventricular tachycardia. Unlike standard treatments, which can be invasive or less targeted, the FlexAbility catheter uses advanced technology to deliver energy directly to heart tissue, potentially reducing the risk of damage to surrounding areas. This specificity not only enhances safety but may also improve the effectiveness of the procedure, offering hope for better outcomes and fewer complications for patients.

What is the effectiveness track record for the FlexAbility SE Ablation Catheter in treating ventricular tachycardia?

Studies have shown that the FlexAbility SE Ablation Catheter, used in this trial, effectively treats ventricular tachycardia, a condition where the heart beats too fast and can be dangerous. Research indicates that this catheter stabilizes the heart's rhythm by using radiofrequency energy to target and destroy problematic heart tissue. Previous patients demonstrated better results with this treatment, particularly those unresponsive to medications. The catheter's design enhances procedural efficiency and consistency, leading to safer and more reliable outcomes. Overall, the FlexAbility SE Catheter has a strong track record for effectively managing this heart condition. ^{1 3 4 5 6}

Who Is on the Research Team?

Kristin Ruffner, PhD

Principal Investigator

Clinical Program Director

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ablation treatment using the FlexAbility SE Catheter

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• FlexAbility SE Ablation Catheter

How Is the Trial Designed?

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

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110016S080B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) effectiveness of RF ablation with the FlexAbility SE Catheter for the treatment of recurrent, drug-refractory, sustained monomorphic ...

2. cardiovascular.abbott cardiovascular.abbott/int/en/hcp/products/electrophysiology/ablation-technology/flexability-se-ablation-catheter/about.html

About the FlexAbility Cardiac Ablation Catheter, SE The FlexAbility Ablation Catheter, SE is intended to yield safe, effective outcomes for your patients1-4 and provide the consistent performance and fatigue- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10774658/

Safety and effectiveness of the first contact force ablation ... TactiFlex SE's flexible tip was more stable than solid catheters; this improved stability and resulted in more efficient procedures.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03490201

FLExAbility Sensor Enabled Substrate Targeted Ablation ... This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110016S080C.pdf

FlexAbility™ Ablation Catheter, Sensor Enabled The LESS-VT IDE study NICM cohort results demonstrate that the FlexAbility™ SE catheter is safe and effective for endocardial or epicardial mapping,.

6. fda.gov fda.gov/medical-devices/recently-approved-devices/flexability-ablation-catheter-sensor-enabled-p110016s080

FlexAbility Ablation Catheter, Sensor Enabled - FDA Summary of Safety and Effectiveness Data (SSED) · Labeling · PMA Database entry. Content current as of: 02/01/2023. Regulated Product(s).