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The purpose of this study is to assess the safety and effectiveness of the Circular and Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated Pulmonary Vein Isolation System when used for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
The study will include a Workflow Phase to verify consistent workflow of all study device components and evaluate acute safety. Upon meeting the defined criteria, the Workflow Phase will be closed and further enrollment will be toward the Main Study Phase which includes the roll-in (the first 3 subjects enrolled at each site following the closure of the Workflow Phase) and Subpopulation Neurological Assessments (SNA) substudy subjects. SNA assessment is a prospective, non-randomized, controlled, acute assessment of two ablation devices to determine if intracerebral microemboli are generated during or immediately after radiofrequency ablation therapy for PAF. SNA subjects will remain and complete the Main Study Phase. However, SNA-control subjects will not be considered part of the Main Study Phase. All subjects, including the subjects enrolled under the Workflow Phase will be included in the Safety Cohort (evaluated for Primary Safety endpoint and all Secondary Safety endpoints).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nMARQ™ System | Experimental | The nMARQ™ System (Circular and Crescent Mapping and Ablation Catheters as well as the Multi-Channel Radiofrequency Generator) as part of the Multi-Electrode Irrigated Pulmonary Vein (PV) Isolation System will serve as a treatment method for subjects undergoing radiofrequency catheter ablation for drug refractory, symptomatic Paroxysmal Atrial Fibrillation (PAF). The study later included a Subpopulation Neurological Assessments (SNA) substudy which is a prospective, non-randomized, controlled, acute assessment to compare subjects treated with the nMARQ™ System against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nMARQâ„¢ System | Device | The nMARQâ„¢ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon. |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Early Onset Primary Adverse Events | The primary safety endpoint is the incidence of early onset primary adverse events within 7 days of the mapping and ablation procedure. Primary adverse events include pericardial effusion requiring intervention, atrial perforation, pericarditis requiring intervention, cardiac tamponade, pneumothorax, death, pulmonary edema, diaphragmatic paralysis, heart block, stroke / cerebrovascular accident (CVA), hospitalization (initial and prolonged), thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), and vascular access complications. In addition, pulmonary vein stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure are deemed primary adverse event. | Any of above events occurring within 7 days post-procedure (also including the incidence of pulmonary vein stenosis and atrio-esophageal fistula occurring > 7 days and up to one year post-procedure) |
| Incidence of Freedom From Documented Symptomatic Atrial Fibrillation | The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation. | Evaluated from Day 91 to Day 240 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months | This secondary safety endpoint includes non-primary serious adverse events within 7 days post-procedure and serious adverse events from 7 days to 12 months post-procedure. | 12 months post study procedure |
| Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Pierre Jais, MD | Hop. Haut-Lévêque | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ St Jan, Cardiologie | Bruges | Belgium | ||||
| Institute for Clinical and Experimental Medicine (IKEM) |
The Main Study consisted only of subjects treated with nMARQ ablation system, without a control arm. Later, a Subpopulation Neurological Assessment (SNA) was added to evaluate for potential cerebral micro-emboli and neurological deficits post ablation. The SNA included a comparator control arm of subjects treated with the Navistar® ThermoCool®.
A total of 186 eligible subjects enrolled in this study across 8 sites in Europe. The first was enrolled on March 14, 2011 and was treated on March 15, 2011. The last was enrolled on October 16, 2012. The study's last 12 month follow-up visit occurred on September 27, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | nMARQâ„¢ (Main Study- Single Arm) | This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQâ„¢ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter. |
| FG001 | NAVISTAR® THERMOCOOL® (SNA Subpopulation Only) | Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits. These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter. Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population (cohort): For the main study, this population includes enrolled subjects who underwent insertion of study catheters. For the NAVISTAR® THERMOCOOL® arm, this population includes enrolled subjects, but excludes two subjects (1 with low pre-ablation international normalized ratio (INR) and 1 missing post procedure neurological exam).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | nMARQâ„¢ (Main Study- Single Arm) | This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQâ„¢ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter. |
| BG001 | NAVISTAR® THERMOCOOL® (SNA Subpopulation Only) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Incidence of Early Onset Primary Adverse Events | The primary safety endpoint is the incidence of early onset primary adverse events within 7 days of the mapping and ablation procedure. Primary adverse events include pericardial effusion requiring intervention, atrial perforation, pericarditis requiring intervention, cardiac tamponade, pneumothorax, death, pulmonary edema, diaphragmatic paralysis, heart block, stroke / cerebrovascular accident (CVA), hospitalization (initial and prolonged), thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), and vascular access complications. In addition, pulmonary vein stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure are deemed primary adverse event. | Safety Population as defined above | Posted | Number | 95% Confidence Interval | percentage of participants | Any of above events occurring within 7 days post-procedure (also including the incidence of pulmonary vein stenosis and atrio-esophageal fistula occurring > 7 days and up to one year post-procedure) |
|
12 Months post study procedure
"Serious Adverse Events"/"Other (Not Including Serious) Adverse Events" tables: for the "NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)" arm the "at Risk #" represents subjects enrolled and treated, including the 1 subject excluded from the SNA analysis due to missing neurological exams. (Excluding the subject not treated).
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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 | nMARQâ„¢ System (Main Study) | nMARQâ„¢ is the Biosense Webster Pulmonary Vein Isolation System consists of Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator. This system is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously for treating paroxysmal atrial fibrillation (PAF). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kendra McInnis, Manager, Clinical Operations | Biosense Webster, Inc | 909-839-7284 | kmcinnis@its.jnj.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D011876 | Radionuclide Generators |
| ID | Term |
|---|---|
| D055618 | Radiation Equipment and Supplies |
| D004864 | Equipment and Supplies |
Not provided
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|
Incidence of narrowing of PV and stenosis at 3 months post ablation, for subjects with available CT/MRA scans at 3 months. PV Stenosis is defined as 70% or more PV diameter reduction. |
| Three months after index ablation |
| Incidence of Completion of Ablation Procedure | This secondary outcome describes the acute effectiveness, which is defined as pulmonary vein isolation (PVI) documented by confirmed entrance block (with or without the use of a focal catheter). | From 7 days to 12 months post study procedure |
| Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure | This endpoint is defined as the absence of documented symptomatic PAF recurrence through 6 months and 12 months post index ablation procedure. | 6 and12 months post study procedure |
| Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation | Evaluation of post-ablation generation incidence of asymptomatic cerebral microembolic lesions post ablation, as documented by MRI. All microembolic lesions reported in this study are asymptomatic. | 48 hours post-ablation |
| Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation | All SNA subjects were to be evaluated by expert neurologists for existing neurological deficits prior to ablation procedure. After procedure, those subjects were also to be assessed for new neurological deficits. | 48 hours post-ablation |
| Prague |
| Czechia |
| HCV HjerteCenter Varde | Varde | DK-6800 | Denmark |
| HHL Hop. Haut-Lévêque | Bordeaux | France |
| HDB CHU de Nancy | Nancy | France |
| HLG Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| OFM Ospedale Generale Regionale | Acquaviva delle Fonti | 70021 | Italy |
| CCM Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Neurological exam not done |
|
Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits. These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter. Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Fifty-three subjects in nMARQ arm and 3 subjects in SNA Control Group didn't report ethnicity and race data because of French privacy law restrictions. These subjects are reported in Race category, "Unknown or Not Reported". | Count of Participants | Participants |
|
| OG000 |
| nMARQâ„¢ (Main Study- Single Arm) |
The Main Study group consists of subjects who were treated with the Biosense Webster nMARQâ„¢ system. This group is single-arm and does not include the SNA substudy population (no comparator group). |
|
|
| Primary | Incidence of Freedom From Documented Symptomatic Atrial Fibrillation | The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation. | Effectiveness cohort: This population excludes those subjects who never underwent insertion of study catheter, those who terminated procedure prior to ablation, and those who were enrolled during the Workflow phase (20 subjects) and Roll-in phase (22 subjects). This analysis also excludes two subjects who withdrew consent post ablation. | Posted | Number | 95% Confidence Interval | percentage of participants | Evaluated from Day 91 to Day 240 |
|
|
|
|
| Secondary | Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months | This secondary safety endpoint includes non-primary serious adverse events within 7 days post-procedure and serious adverse events from 7 days to 12 months post-procedure. | Safety population | Posted | Number | percentage of participants | 12 months post study procedure |
|
|
|
| Secondary | Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation | Incidence of narrowing of PV and stenosis at 3 months post ablation, for subjects with available CT/MRA scans at 3 months. PV Stenosis is defined as 70% or more PV diameter reduction. | Subjects in safety analysis group who also had CT/MRI PV scan available at the 3-month post-ablation interval (144 of 160 subjects) | Posted | Number | percentage of participants with CT/MRI | Three months after index ablation |
|
|
|
| Secondary | Incidence of Completion of Ablation Procedure | This secondary outcome describes the acute effectiveness, which is defined as pulmonary vein isolation (PVI) documented by confirmed entrance block (with or without the use of a focal catheter). | Safety population excluding one subject without source document at site | Posted | Number | 95% Confidence Interval | percentage of participants | From 7 days to 12 months post study procedure |
|
|
|
| Secondary | Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure | This endpoint is defined as the absence of documented symptomatic PAF recurrence through 6 months and 12 months post index ablation procedure. | This analysis population is the effectiveness cohort, excluding 2 subjects who withdrew consent prior to Day 91. The effectiveness cohort includes those who received treatment with the investigational device; but does not include 20 workflow and 22 roll-in subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 and12 months post study procedure |
|
|
|
| Secondary | Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation | Evaluation of post-ablation generation incidence of asymptomatic cerebral microembolic lesions post ablation, as documented by MRI. All microembolic lesions reported in this study are asymptomatic. | Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group. | Posted | Number | percentage of subjects with ACE Lesion | 48 hours post-ablation |
|
|
|
| Secondary | Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation | All SNA subjects were to be evaluated by expert neurologists for existing neurological deficits prior to ablation procedure. After procedure, those subjects were also to be assessed for new neurological deficits. | Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group. | Posted | Number | percentage of participants | 48 hours post-ablation |
|
|
|
| 31 |
| 163 |
| 65 |
| 163 |
| EG001 | NAVISTAR® THERMOCOOL® (SNA Subpopulation Only) | Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits. These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter. Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group. | 0 | 18 | 5 | 18 |
| Atrial tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA (12.0) | Systematic Assessment |
|
| Toxic nodular goitre | Endocrine disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Arterial restenosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Benign neoplasm of adrenal gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Panic disorder | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA (12.0) | Systematic Assessment |
|
| Blindness transient | Eye disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Peritoneal haematoma | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Allergic oedema | Immune system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Polymerase chain reaction | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hemianopia homonymous | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Cardioversion | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
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 |
|---|---|
|
| > 70% Reduction of PV Diameter (Severe) |
|