Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
THERMOCOOL SMARTTOUCH® SF-5D catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
- 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.
Sites / Locations
- OLV Hospital Aalst
- Jessa Hospital
- IKEM
- Na Homolce Hospital
- Skejby _ Aarhus University hospital
- Ospedale Generale Regionale F Miulli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02944968
First Posted
October 21, 2016
Last Updated
November 21, 2019
Sponsor
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02944968
Brief Title
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
August 6, 2018 (Actual)
Study Completion Date
August 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Interventional, Radiofrequency Ablation, Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population.
Intervention Type
Device
Intervention Name(s)
THERMOCOOL SMARTTOUCH® SF-5D catheter
Primary Outcome Measure Information:
Title
Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population
Description
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.
Time Frame
Day of ablation procedure
Secondary Outcome Measure Information:
Title
Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Description
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
Time Frame
Seven Days Post Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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.
Facility Information:
Facility Name
OLV Hospital Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Jessa Hospital
City
Hasselt
Country
Belgium
Facility Name
IKEM
City
Prague
Country
Czechia
Facility Name
Na Homolce Hospital
City
Prague
Country
Czechia
Facility Name
Skejby _ Aarhus University hospital
City
Aarhus
Country
Denmark
Facility Name
Ospedale Generale Regionale F Miulli
City
Bari
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
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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