PFA Ablation for Atrial Fibrillation

(FlexPulse IDE Trial)

Recruiting at 31 trial locations

Overseen By Laura Zitella Verbick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Persistent AF, Heart failure, Stroke, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using the TactiFlex SE Ablation catheter, which helps stop irregular heart rhythms in people with paroxysmal atrial fibrillation (PAF), a condition where the heart beats abnormally. The goal is to determine if this method is both safe and effective for those whose PAF symptoms don't improve with medication. Individuals who have experienced frequent, self-terminating episodes of PAF and plan to undergo catheter ablation due to persistent symptoms might be suitable candidates for this trial. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options for PAF.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be refractory, intolerant, or contraindicated to at least one Class I-IV antiarrhythmic drug, which might imply changes to your current medication regimen.

What prior data suggests that the TactiFlex SE Ablation catheter is safe for treating paroxysmal atrial fibrillation?

Research has shown that the TactiFlex Ablation catheter is safe for treating paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat. Studies have found this catheter to be both safe and effective, enhancing procedural efficiency compared to older versions.

The catheter's design ensures safety and stability during use, enabling doctors to create small, precise areas of scar tissue necessary to halt the irregular heartbeat without causing harm. Reports of safety issues or negative effects related to the TactiFlex catheter are minimal, suggesting it is generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for paroxysmal atrial fibrillation (PAF) involve traditional ablation techniques that use radiofrequency (RF) energy to burn small areas of heart tissue and stop erratic electrical signals. But the TactiFlex Ablation catheter stands out because it offers a flexible tip designed for precise mapping and delivers both RF current and pulsed field ablation (PFA) therapy. This combination allows for more targeted ablation with potentially less damage to surrounding tissues. Researchers are excited about this treatment because it could improve safety and effectiveness, reducing the risk of complications and improving outcomes for patients with PAF.

What evidence suggests that the TactiFlex Ablation catheter is effective for paroxysmal atrial fibrillation?

Research has shown that the TactiFlex SE Ablation catheter, which participants in this trial may receive, effectively treats paroxysmal atrial fibrillation (PAF) in patients unresponsive to medication. Studies have demonstrated that this catheter can safely and effectively manage PAF. It uses radio waves or electrical pulses to target and destroy the heart tissue causing abnormal rhythms. This method results in quicker procedures and better outcomes compared to older techniques. Additionally, catheter ablation is a well-known treatment for atrial fibrillation, and the TactiFlex SE offers improved safety and stability. ^{1 2 4 6 7}

Who Is on the Research Team?

Sarah Kammer

Principal Investigator

Abbott Medical Devices

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing and able to follow all trial requirements.

I understand the trial details and have signed the consent form.

My AFib was confirmed with a 30-second ECG reading.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ablation with the TactiFlex SE Ablation catheter using PFA and/or RF generator

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits as per protocol

What Are the Treatments Tested in This Trial?

Interventions

• PFA Ablation catheter

How Is the Trial Designed?

Group I: TactiFlex Ablation catheter Experimental Treatment 1 Intervention

A single use catheter that is designed to facilitate electrophysiological mapping of the heart chambers and to transmit RF current or PFA therapy to the catheter's flexible tip electrode for intracardiac ablation purposes.

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. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/electrophysiology/ablation-technology/tactiflex-se-ablation-catheter.html

TactiFlex™ Ablation Catheter, Sensor Enabled TactiFlex™ Ablation Catheter, Sensor Enabled™ is designed for optimal safety and stability, confident lesion creation and procedural efficiency.

2. jafib-ep.com jafib-ep.com/wp-content/uploads/2023/10/TactiFlex%E2%84%A2-Ablation-Catheter-Sensor-Enabled%E2%84%A2-Initial-Experience-from-the-TactiFlex-AF-IDE-Trial-and-in-Japan-After-Early-Market-Release.pdf

TactiFlex™ Ablation Catheter, Sensor Enabled that catheter ablation is an established therapy for atrial fibrillation.18-20. Growing data that show superior outcomes with lower rate of tachyarrhythmia ...

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

Safety and effectiveness of the first contact force ablation ... TactiFlex SE is safe and effective for treatment of drug-refractory PAF and concomitant AFL and enables more efficient procedures than previous generation ...

4. electrophysiology.abbott.com electrophysiology.abbott.com/rs/808-JQJ-642/images/TFSE_Economic_Value_Document_External_US_MAT_2306155_v2.pdf

TactiFlex™M - Ablation Catheter, SE TactiFlex IDE data includes a 20-minute waiting period, and TactiSense IDE data includes a 30-minute waiting period. The TactiSense IDE was the PAF IDE ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06676072

NCT06676072 | A Study of the TactiFlex SE Catheter and ... This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=23106425&pc=OAE

Catheter, percutaneous, cardiac ablation, for treatment of atrial ... MAUDE Adverse Event Report: ABBOTT MEDICAL TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿; Catheter, percutaneous, cardiac ablation, for treatment of atrial ...

7. electrophysiology.abbott.com electrophysiology.abbott.com/rs/808-JQJ-642/images/TactiFlex_Clinical_Compendium_External_US_MAT-2306314_v1.0_FINAL.pdf

CLINICAL COMPENDIUM The acute data results indicate that TactiFlex Ablation Catheter, SE, is ACUTELY SAFE AND EFFECTIVE. AT BOTH HIGH AND LOW-POWER for ablation of ...