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.

NCT03459196 | Completed Results DMC FDA Device

• 1 other identifier: BWI_2017_02
• Study Type: interventional
• Target: 54
• Locations: 4 countries
• Sites: 7

Brief Summary

The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Interventional; Radiofrequency Ablation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Achieved Acute Procedural Success

  Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.

  Day 1

• Incidence of Acute Safety

  Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.

  7 days post-procedure

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Interventions

THERMOCOOL SMARTTOUCH SF-5D Catheter DEVICE

radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• Signed the Patient Informed Consent Form (ICF).
• Diagnosed with symptomatic PAF
• Selected for catheter ablation through pulmonary vein isolation.
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patient not confined by a court ruling).

You may not qualify if:

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous surgical or catheter ablation for atrial fibrillation.
• Previously diagnosed with persistent, longstanding AF and/or continuous AF \>7 days, or \>48 hrs. terminated by cardioversion.
• Documented Left Atrial thrombus on baseline/pre-procedure imaging.
• Any carotid stenting or endarterectomy.
• Left atrial (LA) size \>50mm.
• Left Ventricular ejection fraction (LVEF) \<40%.
• Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
• History of blood clotting or bleeding abnormalities
• Contraindication to anticoagulation
• History of a documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months.
• Previous percutaneous coronary intervention (PCI) or myocardial Infarction (MI) within the past 2 months.
• Coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.
• Rheumatic Heart Disease
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (7)

Elisabethinen Hospital

Linz, Austria

Location

OLV Aalst

Aalst, Belgium

Location

AZ Sint-Jan

Bruges, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Ceské Budejovice Hospital

České Budějovice, Czechia

Location

Na Homolce

Prague, Czechia

Location

Ospedale F Miulli

Bari, Italy

Location

Related Publications (1)

• Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, Martinek M, Natale A, Knecht S, Neuzil P, Purerfellner H. Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial. JACC Clin Electrophysiol. 2019 Jul;5(7):778-786. doi: 10.1016/j.jacep.2019.04.009. Epub 2019 May 8.

  PMID: 31320006 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nathalie Macours / Clinical Research Director
• Organization: Johnson and Johnson Medical NV/SA

nmacours1@its.jnj.com

+32 2 746 35 27

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 8, 2018
• Study Start: April 2, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: June 29, 2025
• Results First Posted: November 6, 2019

Record last verified: 2025-06

Locations

IT (1); CZ (2); AU (1); BE (3)