NCT02310100

TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

Detailed description

The TactiCath Quartz PAS is a prospective, non-randomized, multicenter, interventional study to evaluate the continued safety and effectiveness of the TactiCath Quartz Set for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using contact force assisted irrigated RF ablation. Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated following the standard of care at each study site. After the index procedure, subjects will be followed for a total of 60 months. During the 3-month blanking period following ablation, subjects may undergo up to 2 repeat ablation procedures (up to 10 days prior to end of the blanking period) using the same device used during ablation. Subjects will be evaluated at pre-discharge, at 7 days, at 3, 6 and 12 months post-index procedure and then yearly thereafter. Subjects will complete Holter monitoring at 3- and 6- months post index ablation procedure and at yearly intervals beginning at 12 months post-index ablation procedure.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	TactiCath Quartz treatment

Timeline

• Start date: 2015-01-21
• Primary completion: 2017-02-01
• Completion: 2021-09-17
• First posted: 2014-12-05
• Last updated: 2021-10-12
• Results posted: 2019-03-28

Locations

20 sites across 1 country: United States