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The sponsor decided to terminate the study early due to enrolment not proceeding in accordance with expectations, independently from the study outcome.
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The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.
Eligible PAF subjects with recurrent AF for 2 years who have failed no more than 2 prescribed drugs (with either anti-arrhythmic or rate control drug) are randomized into one of two study arms (catheter ablation or drug therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Ablation | Experimental | Radiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF) |
|
| Drug Treatment | Active Comparator | Drug therapy (either rate or rhythm control) using current AF management guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Device | Treat subjects with Paroxysmal Atrial Fibrillation (PAF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years | Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | 1 year |
| Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years |
Not provided
Inclusion Criteria:
Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )
HATCH Score of at least ≥1 and ≤4.
Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
Age 60 years or older.
Left atrium (LA) diameter ≤ 55mm by TTE.
Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection fraction ≥35% when in atrial fibrillation.
NOTE: For patients entering the study in AF with an ejection fraction ≥35% and <50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is >50% the subject can continue in the study.
Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.
Exclusion Criteria:
NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to exclude, if the patient develops subsequent recurrent atrial fibrillation.
NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal Echocardiography (TEE) should be performed (as per standard of care), within 48 hours pre-procedure, to exclude atrial thrombus or other structural contraindications for an ablation procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Kuck, MD | Asklepios Klinik St. Georg | Principal Investigator |
Not provided
Before randomization and signing inform consent forms, all subjects were screened according protocol defined inclusion and exclusion criteria. Screening failures were excluded from the study and were not randomized.
The first subject was enrolled on 13-Feb-2012. On 27-Feb-2018, study was terminated early due to enrollment not proceeding in accordance with expectations, independently from the study outcome. The last subject completed the last visit on 29-May-2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency (RF) Ablation Treatment | Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™). |
| FG001 | Antiarrhythmic Drug (AAD) Therapy | Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The intent-to-treat population included all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency (RF) Ablation Treatment | Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™). |
| BG001 | Antiarrhythmic Drug (AAD) Therapy |
| 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 | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years | Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. | Posted | Median | 95% Confidence Interval | Months | 3 years |
|
3 years follow up
Adverse events are summarized using the Safety population, which includes all subjects who had undergone insertion of an ablation catheter, either as RF ablation group or cross-over subjects; subjects who had started an investigator prescribed AAD in the AAD Group and did not initiate ablation therapy.
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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 | Radiofrequency (RF) Ablation Treatment | Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
As the study was terminated early without having met primary effectiveness or futility criteria, the study results should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liesbeth Vanderlinden | Johnson & Johnson Medical N.V., Biosense Webster | +32 (0) 2 746 3446 | lvanderl@its.jnj.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2013 | Dec 18, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2018 | Dec 18, 2019 | SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
Not provided
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| Drug Treatment | Drug | Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines. |
|
|
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. |
| 2 years |
| Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | 1 year |
| Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | 2 Years |
| Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | 3 year |
| Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | 3 years |
| Number of Repeat Ablations | Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is >= 2, then subject had at least one repeat procedure. | 3 years |
| Number of New Antiarrhythmic Drugs | Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines. | 3 years |
| Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit | 3 months, 6 months, 1 year, 2 years, 3 years |
| Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit | 3 months, 6 months, 1 year, 2 year and 3 years |
| Subject excluded |
|
| Subject withdrew consent |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Death |
|
| Other |
|
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment). |
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Antiarrhythmic Drug (AAD) Therapy |
Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment). |
|
|
|
| Secondary | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. | Posted | Median | 95% Confidence Interval | Months | 1 year |
|
|
|
|
| Secondary | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. | Posted | Median | 95% Confidence Interval | Months | 2 years |
|
|
|
|
| Secondary | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 year |
|
|
|
| Secondary | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. | Posted | Number | 95% Confidence Interval | Percentage of participants | 2 Years |
|
|
|
| Secondary | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 3 year |
|
|
|
| Secondary | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. | Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Endpoint applicable only to subjects randomized into the test group. | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 years |
|
|
|
| Secondary | Number of Repeat Ablations | Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is >= 2, then subject had at least one repeat procedure. | Subjects in the Intent to treat population (ITT) who were randomized to RF ablation or who received any RF ablations as Cross-Over Patients randomized to AAD group. ITT population includes all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. | Posted | Mean | Standard Deviation | Event of ablation | 3 years |
|
|
|
| Secondary | Number of New Antiarrhythmic Drugs | Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines. | Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. | Posted | Mean | Standard Deviation | AAD drug | 3 years |
|
|
|
| Secondary | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit | Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of participants analyzed at each visit is the number of participants with available data at the visit. | Posted | Number | Participants | 3 months, 6 months, 1 year, 2 years, 3 years |
|
|
|
| Secondary | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit | Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of participants analyzed at each visit is the number of participants with available data at the visit. | Posted | Number | Participants | 3 months, 6 months, 1 year, 2 year and 3 years |
|
|
|
| 5 |
| 102 |
| 38 |
| 102 |
| 37 |
| 102 |
| EG001 | Antiarrhythmic Drug (AAD) Therapy Only | Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. This group includes only those subjects received AAD only. | 4 | 108 | 30 | 108 | 43 | 108 |
| EG002 | Antiarrhythmic Drug (AAD) Therapy - First Treatment | This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the AAD treatment period. | 0 | 15 | 7 | 15 | 6 | 15 |
| EG003 | Radiofrequency (RF) Ablation - Second Treatment | This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the RF treatment period. | 0 | 15 | 4 | 15 | 4 | 15 |
| Acute coronary syndrome | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Intracardiac thrombus | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Ventricular tachyarrhythmia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA v19.0 | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Perineal abscess | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Prostate infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Arteriogram coronary | Investigations | MedDRA v19.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Benign neoplasm of bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Nerve degeneration | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Radicular syndrome | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Device lead damage | Product Issues | MedDRA v19.0 | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA v19.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Abscess drainage | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
|
| Cardiac ablation | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | MedDRA v19.0 | Systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
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| Aortic valve incompetence | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Atrial thrombosis | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Cardiac valve disease | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA v19.0 | Systematic Assessment |
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| Deafness | Ear and labyrinth disorders | MedDRA v19.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA v19.0 | Systematic Assessment |
|
| Thyroid disorder | Endocrine disorders | MedDRA v19.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA v19.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Systemic infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA v19.0 | Systematic Assessment |
|
| Electrocardiogram change | Investigations | MedDRA v19.0 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA v19.0 | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA v19.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Prostatic disorder | Reproductive system and breast disorders | MedDRA v19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA v19.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v19.0 | 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.
| D013514 |
| Surgical Procedures, Operative |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 2 or more ablations |
|
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| 6 month follow up |
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| 1 year follow up |
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| 2 year follow up |
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| 3 year follow up |
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| 6 month follow up |
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| 1 year follow up |
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| 2 year follow up |
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| 3 year follow up |
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