Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation. (QDOT-FAST)
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|ClinicalTrials.gov Identifier: NCT03459196|
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment|
|Paroxysmal Atrial Fibrillation||Device: THERMOCOOL SMARTTOUCH SF-5D Catheter|
The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.|
|Anticipated Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||January 31, 2020|
Experimental: Treatment Group
A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including TGA mode (Temperature Guided Ablation).
Device: THERMOCOOL SMARTTOUCH SF-5D Catheter
radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode
- Acute Device Performance [ Time Frame: Intraoperative ]Acute Procedural Success defined as confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge.
- Incidence of Primary Adverse Events (PAEs) (within 7 days of the initial mapping and ablation procedure). [ Time Frame: 7 days ]
The incidence of Primary Adverse Events (PAEs) (within 7 days of the initial mapping and ablation procedure). PAEs include the following AEs:
- Atrio-esophageal Fistula
- Cardiac Tamponade/perforation
- Major Vascular Access Complication/Bleeding
- Myocardial Infarction
- Phrenic Nerve Paralysis
- Pulmonary Vein Stenosis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459196
|OLV Aalst||Not yet recruiting|