Paroxysmal Atrial FibrillationQDOT-FASTNCT03459196
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.
A study testing THERMOCOOL SMARTTOUCH SF-5D Catheter in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 7 sites in 4 countries.
Trial summary
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- THERMOCOOL SMARTTOUCH SF-5D Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 2 Apr 2018to 8 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 32Show fewer
- 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.
- Unstable angina.
- Significant pulmonary disease (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other diseaseor malfunction of the lungs or respiratory system that produces chronic symptoms.
- Acute illness, active systemic infection, or sepsis.
- Presence of atrial myxoma, interatrial baffle or patch
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
- Presence of a condition that precludes vascular access.
- Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD).
- Presence of IVC filter
- Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
- Currently enrolled in an investigational study evaluating another device, biologic, or drug.
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
- Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
- Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
- Presence of iron-containing metal fragments in the body
- Unresolved pre-existing neurological deficit.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
About this study
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
Read the detailed description
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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- THERMOCOOL SMARTTOUCH SF-5D Catheter
- Keywords
- Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERMOCOOL SMARTTOUCH SF-5D CatheterDevice
radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: THERMOCOOL SMARTTOUCH SF-5D Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start2 Apr 2018
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459196
- Sponsor's protocol ID
- BWI_2017_02
- Acronym
- QDOT-FAST
- Status last verified
- Jun 2025
- First submitted
- 23 Feb 2018
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 31320006
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03459196
- Acronym / sponsor ID
- QDOT-FAST / BWI_2017_02
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: THERMOCOOL SMARTTOUCH SF-5D CatheterA 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERMOCOOL SMARTTOUCH SF-5D Catheterradiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode | Device | Treatment Group |
Primary outcome
Number of Subjects Achieved Acute Procedural Success
Time frame: Day 1
Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
Incidence of Acute Safety
Time frame: 7 days post-procedure
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31320006Reddy 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THERMOCOOL SMARTTOUCH SF-5D Catheter in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Czechia, Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Achieved Acute Procedural Success (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.