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The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THERMOCOOL SMARTTOUCH® SF-5D catheter | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Candidates for this study must meet ALL of the following criteria:
Exclusion Criteria:
Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:
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Subjects were screened carefully prior to enrollment in the study to ensure compliance with the inclusion and exclusion criteria. All subjects had pre-procedure imaging to screen for the presence of left atrial appendage thrombus to decrease the potential for thromboembolic complications.
A total of 51 subjects were enrolled in the study at 6 sites in Europe. The first subject was enrolled on September 28th, 2016 and the last subject was enrolled on April 26th, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | THERMOCOOL SMARTTOUCH® SF-5D | The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2017 | Aug 5, 2019 |
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| Seven Days Post Procedure |
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| COMPLETED | Evaluable subjects (under protocol v1.0 and v2.0) who completed the study. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | THERMOCOOL SMARTTOUCH® SF-5D | The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This total effectiveness outcome population includes all subjects (under both protocols v1.0 and v2.0), complied with study inclusion and exclusion criteria, received investigational device, and had an adenosine challenge applied for verifying entrance block. | Posted | Count of Participants | Participants | Day of ablation procedure |
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| Secondary | 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 | Total Safety Population: includes subjects enrolled under CIP v1.0 and 2.0 who underwent study procedure with investigational device. | Posted | Count of Participants | Participants | Seven Days Post Procedure |
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Three months follow up after procedure
An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | THERMOCOOL SMARTTOUCH® SF-5D | The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology | 0 | 50 | 7 | 50 | 22 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA V19.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA V19.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA V19.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA V19.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA V19.0 | Systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA V19.0 | Systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V19.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA V19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA V19.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA V19.0 | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | MedDRA V19.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA V19.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA V19.0 | Systematic Assessment |
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| Thyroid disorder | Endocrine disorders | MedDRA V19.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA V19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA V19.0 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA V19.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA V19.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA V19.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA V19.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA V19.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA V19.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA V19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V19.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA V19.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V19.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA V19.0 | Systematic Assessment |
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| Perforation | General disorders | MedDRA V19.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA V19.0 | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA V19.0 | Systematic Assessment |
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There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Macours, Clinical Research Director | Johnson and Johnson Medical NV/SA | +32 2 746 35 27 | nmacours1@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 2, 2018 | Aug 5, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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