PFA Ablation for Atrial Fibrillation
(FlexPulse IDE Trial)
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.12345Why 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.12467
Who Is on the Research Team?
Sarah Kammer
Principal Investigator
Abbott Medical Devices
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ablation with the TactiFlex SE Ablation catheter using PFA and/or RF generator
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PFA Ablation catheter
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
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.htmlTactiFlex™ Ablation Catheter, Sensor Enabled
TactiFlex™ Ablation Catheter, Sensor Enabled™ is designed for optimal safety and stability, confident lesion creation and procedural efficiency.
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 ...
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.pdfTactiFlex™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 ...
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=OAECatheter, 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.pdfCLINICAL 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 ...
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