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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03459196|
Recruitment Status : Active, not recruiting
First Posted : March 8, 2018
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Device: THERMOCOOL SMARTTOUCH SF-5D Catheter||Not Applicable|
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)|
|Actual Enrollment :||52 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.|
|Actual Study Start Date :||April 2, 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
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): NCT03459196
|Ceské Budejovice Hospital|
|Ceské Budejovice, Czechia|
|Ospedale F Miulli|