Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT03650556|
Recruitment Status : Completed
First Posted : August 28, 2018
Results First Posted : April 27, 2022
Last Update Posted : April 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation||Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)|
|Actual Study Start Date :||September 28, 2018|
|Actual Primary Completion Date :||December 21, 2020|
|Actual Study Completion Date :||January 11, 2021|
Enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE).
Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Ablation procedure for Persistent AF
- Rate of Subjects With a Device and/or Procedure-related SAE. [ Time Frame: Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure ]Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.
- Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. [ Time Frame: 15 months ]
The following events were considered a failure for AF/AFL/AT recurrence:
- If AF/AFL/AT recurrence (>30 second episode) occurred at any time after the therapy consolidation period (>180 days after the initial procedure), or
- If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a >30 second AF/AFL/AT episode, or
- If the subject required a second repeat procedure at any time after the initial procedure, or
- If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or
- If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or
- If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the
- Acute Procedural Success [ Time Frame: Immediate post procedure ]Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins
- 15-month Success Off of Antiarrhythmic Drugs [ Time Frame: 15 months ]Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods.
- 15 Month Single Procedure Success [ Time Frame: 15 months ]Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650556