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This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | THERMOCOOL® SMARTTOUCH™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THERMOCOOL® SMARTTOUCH™ | Device | Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes | The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period). | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Where Acute Success Was Achieved | Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study. | 0.5 hours |
| Average Contact Force Per Pulmonary Vein Ablation Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Congxin Huang | Renmin Hospital of Wuhan University | Principal Investigator |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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This was a prospective, multicenter, non-randomized clinical study. Patients were enrolled to receive THERMOCOOL® SMARTTOUCHTM catheter if signed informed consent forms and satisfied the study inclusion and exclusion criteria.
A total of 201 patients from 12 sites in China were screened and 200 patients were enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | THERMOCOOL® SMARTTOUCH™ Family of Catheters | Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | THERMOCOOL® SMARTTOUCH™ Family of Catheters | Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All enrolled subjects |
| 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 | Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes | The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period). | Per protocol population: Subjects in the ITT Population who undergone insertion of the study catheter and AF ablation procedure, and had the 12th month primary efficacy endpoint data. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 Months |
|
12 months after ablation procedure
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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™ Family of Catheters | Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kendra McInnis | Biosense Webster, Inc. | 949-450-7783 | kmcinnis@its.jnj.com |
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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 | Jan 7, 2016 | Jul 3, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2016 | Jul 3, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data |
| 1 day during procedure |
| Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure | Percentage of subjects with PV reconnection after the first ablation | 1 day during procedure |
| Procedure Time, Ablation Time and Fluoroscopy Time | Procedure Time, Ablation Time and Fluoroscopy Time in minutes | 1 day during procedure |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | All enrolled subjects | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race/Ethnicity categories related to Chinese are used since the study was conducted in China | All enrolled subjects | Number | Participants |
|
|
|
|
| Secondary | Percentage of Patients Where Acute Success Was Achieved | Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study. | Safety Population, i.e., all enrolled subjects who undergone insertion of the study catheter during the procedure | Posted | Number | 95% Confidence Interval | Percentage of participants | 0.5 hours |
|
|
|
|
| Secondary | Average Contact Force Per Pulmonary Vein Ablation Procedure | Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data | Safety population with contact force data available | Posted | Mean | Standard Deviation | Grams | 1 day during procedure |
|
|
|
| Secondary | Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure | Percentage of subjects with PV reconnection after the first ablation | Safety population with pulmonary vein reconnection data available | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 day during procedure |
|
|
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| Secondary | Procedure Time, Ablation Time and Fluoroscopy Time | Procedure Time, Ablation Time and Fluoroscopy Time in minutes | Safety population | Posted | Mean | Standard Deviation | Minutes | 1 day during procedure |
|
|
|
| 1 |
| 200 |
| 26 |
| 200 |
| 28 |
| 200 |
| Pneumonia | Infections and infestations | MedDRA v18.0.3 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Coronary heart disease | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Syncope | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v18.0.3 | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA v18.0.3 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA v18.0.3 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v18.0.3 | Systematic Assessment |
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| Mixed connective tissue disease | Musculoskeletal and connective tissue disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.0.3 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.0.3 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.0.3 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Ischaemia | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Gas poisoning | Injury, poisoning and procedural complications | MedDRA v18.0.3 | Systematic Assessment |
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| Arteriogram coronary | Investigations | MedDRA v18.0.3 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Ecchymosis | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA v18.0.3 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Vessel puncture site haematoma | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Vessel puncture site haemorrhage | Vascular disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v18.0.3 | Systematic Assessment |
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| Wound secretion | Injury, poisoning and procedural complications | MedDRA v18.0.3 | 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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|