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Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)

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ClinicalTrials.gov Identifier: NCT02944968
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief Summary:
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: THERMOCOOL SMARTTOUCH® SF-5D catheter Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population.
Device: THERMOCOOL SMARTTOUCH® SF-5D catheter



Primary Outcome Measures :
  1. Acute Device Performance [ Time Frame: Intraoperative ]
    Acute Device Performance is defined as confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge


Secondary Outcome Measures :
  1. Incidence of any early onset (within 7 days of ablation procedure) Adverse Events (AE) [ Time Frame: 7 days ]

    The early onset safety is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below:

    • Death
    • Atrio-esophageal fistula*
    • Cardiac Tamponade**+/Perforation+
    • Myocardial infarction (MI)
    • Stroke / Cerebrovascular accident (CVA) †, ††
    • 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

  2. Incidence of Serious Adverse Device Effects (SADEs) [ Time Frame: 30 days post-procedure ]
    Incidence of Serious Adverse Device Effects (SADEs) during follow-up period (3 month)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

  1. Age 18 or older
  2. Patients who have signed the Patient Informed Consent Form (ICF)
  3. Subjects diagnosed with symptomatic documented PAF* who are candidates for catheter ablation
  4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (eg. Patient not confined by a court ruling)

Exclusion Criteria:

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:

  1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  2. Previous ablation for atrial fibrillation.
  3. Previously diagnosed with persistent AF.
  4. Documented Left Atrial thrombus
  5. Any carotid stenting or endarterectomy
  6. LA size >50mm
  7. LVEF <40%
  8. Uncontrolled heart failure or NYHA function class III and IV
  9. History of blood clotting or bleeding abnormalities or contraindication to anticoagulation ( heparin, warfarin, or dabigatran)
  10. History of a documented thromboembolic event (including TIA) within the past 12 months.
  11. Previous PCI/MI within the past 3 months
  12. 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.
  13. Awaiting cardiac transplantation or other cardiac surgery within the next 6 months.
  14. Unstable angina
  15. 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.
  16. Acute illness, active systemic infection, or sepsis.
  17. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
  18. Presence of a condition that precludes vascular access.
  19. Presence of implantable cardioverter-defibrillator (ICD)
  20. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
  21. Currently enrolled in an investigational study evaluating another device, biologics, or drug.
  22. 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).
  23. Life expectancy less than 12 months.
  24. Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.

Information from the National Library of Medicine

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): NCT02944968


Contacts
Contact: Nathalie Macours nmacours1@its.jnj.com

Locations
Belgium
OLV Hospital Aalst Recruiting
Aalst, Belgium, 9300
Contact: Tom De Potter, MD         
Principal Investigator: Tom De Potter, MD         
Jessa Hospital Not yet recruiting
Hasselt, Belgium
Czechia
IKEM Recruiting
Prague, Czechia
Na Homolce Hospital Recruiting
Prague, Czechia
Denmark
Skejby _ Aarhus University hospital Recruiting
Aarhus, Denmark
Italy
Ospedale Generale Regionale F Miulli Not yet recruiting
Bari, Italy
Sponsors and Collaborators
Biosense Webster, Inc.

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT02944968     History of Changes
Other Study ID Numbers: MQDT-166
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biosense Webster, Inc.:
Interventional
Radiofrequency Ablation
Paroxysmal Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes