TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

Status Completed

Clinical Trial Summary

Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Clinical Trial Description

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for treating drug-refractory, symptomatic paroxysmal atrial fibrillation. This clinical investigation will be conducted under an investigational device exemption and is intended to support market approval of the TactiFlex SE catheter worldwide. Three hundred and Fifty Five (355) subjects will be enrolled at up to 50 investigational sites worldwide. This clinical investigation is sponsored by Abbott. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04356040
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	June 29, 2020
Completion date	July 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05970120` - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter	N/A
Recruiting	`NCT06014996` - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.	N/A
Completed	`NCT03624881` - Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)	Phase 4
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Recruiting	`NCT05905835` - Treatment of PAF With the Synaptic System	N/A
Active, not recruiting	`NCT05534581` - SINGLE SHOT CHAMPION	Phase 4
Active, not recruiting	`NCT05618340` - PFA for Paroxysmal Atrial Fibrillation	N/A
Not yet recruiting	`NCT05024630` - Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension	N/A
Completed	`NCT02610803` - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke	N/A
Completed	`NCT01913522` - Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration	N/A
Terminated	`NCT01925885` - Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)	N/A
Withdrawn	`NCT01917981` - Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation	Phase 3
Completed	`NCT01693107` - Atrial Fibrillation Force Contact Ablation Study
Completed	`NCT01842529` - Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery	Phase 2
Completed	`NCT00971204` - Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation	Phase 2
Completed	`NCT05043883` - Automated Assessment of PVI Using a Novel EP Recording System	N/A
Recruiting	`NCT05172765` - Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)	N/A
Recruiting	`NCT04529785` - Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation	N/A
Completed	`NCT04022954` - HD Mapping of Atrial Fibrillation in Asia Pacific
Completed	`NCT00964392` - NAVISTAR® THERMOCOOL® Catheter Post Approval Registry	Phase 4