Atrial FibrillationNCT02944968
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
A study testing THERMOCOOL SMARTTOUCH® SF-5D catheter in people with Atrial Fibrillation, run by Biosense Webster, Inc..
Trial summary
The QDOT-Micro 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
- 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
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 6 Aug 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
- Candidates for this study must meet ALL of the following criteria:
- Age 18 or older
- Patients who have signed the Patient Informed Consent Form (ICF)
- Subjects diagnosed with symptomatic documented PAF* who are candidates for catheter ablation
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements (eg. Patient not confined by a court ruling)
Who cannot join
- Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous ablation for atrial fibrillation.
- Previously diagnosed with persistent AF.
- Documented Left Atrial thrombus
- Any carotid stenting or endarterectomy
Show all 25Show fewer
- LA size >50mm
- LVEF <40%
- Uncontrolled heart failure or NYHA function class III and IV
- History of blood clotting or bleeding abnormalities or contraindication to anticoagulation ( heparin, warfarin, or dabigatran)
- History of a documented thromboembolic event (including TIA) within the past 12 months.
- Previous PCI/MI within the past 3 months
- Previous cardiac surgery (e.g CABG) in conjunction with valve surgery or any valvular cardiac surgical/percutaneous procedure (e.g ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve) within the past 6 months.
- Awaiting cardiac transplantation or other cardiac surgery within the next 6 months.
- Unstable angina
- Significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- Acute illness, active systemic infection, or sepsis.
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
- Presence of a condition that precludes vascular access.
- Presence of implantable cardioverter-defibrillator (ICD)
- 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, biologics, or drug.
- Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation (as evidenced by pregnancy test if of child bearing potential).
- Life expectancy less than 12 months.
- Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
About this study
Official title: Clinical Study for Workflow and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System (the THERMOCOOL SMARTTOUCH® SF-5D Catheter With Temperature Sensing Capabilities and Micro Electrodes and CARTO 3 V 6.0 Technology) in Treatment of Patients With Paroxysmal Atrial Fibrillation (QDOT-Micro)
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
Read the detailed description
The purpose of this study is to evaluate the workflow and acute performance , during standard electrophysiology mapping and RF ablation procedures, of the THERMOCOOL SMARTTOUCH® SF-5D catheter with temperature sensing capabilities and micro electrodes used in combination with the CARTO® 3 Navigation System with THERMOCOOL SMARTTOUCH® SF-5D-module.
- Conditions
- 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
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population. 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 Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population
Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.
Measured: Day of ablation procedure
Secondary outcomes (1)
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Primary adverse events include Death, Atrio-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Vagal Nerve Injury, Pericarditis, Major Vascular Access Complication/Bleeding, Pulmonary vein (PV) stenosis and atrio-esophageal fistula
Measured: Seven 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 posted26 Oct 2016 (estimated)
- Study start1 Sep 2016
- Primary completion6 Aug 2018
- Study completion6 Aug 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.
- Other trials for 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
- 51 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
- NCT02944968
- Sponsor's protocol ID
- MQDT-166
- Status last verified
- Jan 2025
- First submitted
- 21 Oct 2016
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Workflow and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System (the THERMOCOOL SMARTTOUCH® SF-5D Catheter With Temperature Sensing Capabilities and Micro Electrodes and CARTO 3 V 6.0 Technology) in Treatment of Patients With Paroxysmal Atrial Fibrillation (QDOT-Micro)
- ClinicalTrials.gov ID
- NCT02944968
- Acronym / sponsor ID
- MQDT-166
- Conditions
- Atrial Fibrillation
- Keywords
- Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 6 Aug 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Posted 18 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-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
Detailed description
The purpose of this study is to evaluate the workflow and acute performance , during standard electrophysiology mapping and RF ablation procedures, of the THERMOCOOL SMARTTOUCH® SF-5D catheter with temperature sensing capabilities and micro electrodes used in combination with the CARTO® 3 Navigation System with THERMOCOOL SMARTTOUCH® SF-5D-module.
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 catheterRadiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population. |
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
- Patients who have signed the Patient Informed Consent Form (ICF)
- Subjects diagnosed with symptomatic documented PAF* who are candidates for catheter ablation
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements (eg. Patient not confined by a court ruling)
Key exclusion criteria (25 listed)
- Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous ablation for atrial fibrillation.
- Previously diagnosed with persistent AF.
- Documented Left Atrial thrombus
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 catheter | Device | Treatment group |
Primary outcome
Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population
Time frame: Day of ablation procedure
Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.
1 secondary outcome
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Time frame: Seven Days Post Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing THERMOCOOL SMARTTOUCH® SF-5D catheter in people with Atrial Fibrillation, run by Biosense Webster, Inc..
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 25 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 18 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 Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population (time frame: Day of ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.