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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of the prospective, randomized cohort in this study is to assess the safety and efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects planned to undergo catheter ablation for the treatment of non-valvular atrial fibrillation (NVAF).
Simultaneously, a retrospective cohort of 300 warfarin-treated individuals, identified by chart review, who are matched to the prospective randomized subjects, will be identified. The purpose of the retrospective warfarin cohort is to compare the efficacy and safety of warfarin(the current clinical practice) to that of apixaban (uninterrupted, interrupted, combined uninterrupted and interrupted).
Prospective, Randomized Cohort
Subjects undergoing ablation for NVAF who meet all eligibility criteria and sign informed consent will be enrolled into the study. Subjects will be treated with apixaban for ≥21 days prior to the ablation procedure (for subjects already on apixaban for ≥21 days, it is not necessary to wait 21 days before the ablation procedure. Apixaban dose will be 5 mg b.i.d. per product label, or 2.5 mg b.i.d. in subjects with 2 or more of the following: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL.
Eligible subjects will then be randomized in a 1:1 ratio to 2 peri-procedural treatment strategies:
Randomization will take place prior to the procedure (on the day of the procedure or up to 3 days prior to the procedure) and will be stratified by site.
It is anticipated that up to 360 subjects may be enrolled in order to evaluate a total of 300 randomized subjects (150 subjects per treatment arm):
Randomized subjects will continue treatment with apixaban for 1 month post procedure.
Retrospective, Warfarin Cohort In addition, a chart review of 300 warfarin-treated patients who underwent catheter ablation for NVAF on or after September 1, 2013 in the enrolling centers and who have documented follow-up in the medical record for ≥ 30 days post-ablation procedure will be performed. Patient records for warfarin-treated individuals who meet the applicable inclusion/exclusion criteria and who are matched 1:1 to a subject in the prospective, randomized cohort for age (+/- 5 years), gender and atrial fibrillation (AF) type (paroxysmal vs. persistent), will be identified. Sites will document key demographic and outcome variables. This review will be performed in a blinded manner such that site personnel are blinded to the outcome of each retrospective subject during the subject selection process. Only pre-existing data will be collected for the analysis of this cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interrupted apixaban | Active Comparator | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. |
|
| Uninterrupted apixaban | Experimental | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interrupted apixaban | Drug | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinically-Significant Bleeding | Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. | Randomization to 1 month post catheter ablation |
| Number of Patients With Thrombotic Events | Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. | Randomization to 1 month post catheter ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Composite of Major Bleeding and Thrombotic Events | Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. | Randomization to 1 month post catheter ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinically-Significant Bleeding | Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. | Enrollment to 1 month post catheter ablation |
| Number of Patients With Major Bleeding |
Inclusion Criteria:
Signed informed consent.
>18 years of age.
NVAF with planned catheter ablation treatment.
Planned anticoagulant treatment for at least 1 month after the index procedure.
Subject agrees to all required follow-up procedures and visits.
For women of childbearing potential (WOCBP):
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a total of 93 days post-treatment completion.
Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as described in this section.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Reynolds, MD, MSc | Lahey Hospital & Medical Center | Principal Investigator |
| Christopher P Cannon, MD | Harvard Clinical Research Organization and Cardiovascular Division Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 0020 | Huntsville | Alabama | 35801 | United States | ||
| Site 0005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34674223 | Derived | Bawazeer GA, Alkofide HA, Alsharafi AA, Babakr NO, Altorkistani AM, Kashour TS, Miligkos M, AlFaleh KM, Al-Ansary LA. Interrupted versus uninterrupted anticoagulation therapy for catheter ablation in adults with arrhythmias. Cochrane Database Syst Rev. 2021 Oct 21;10(10):CD013504. doi: 10.1002/14651858.CD013504.pub2. | |
| 29798783 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interrupted Apixaban | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2016 | Jan 30, 2020 |
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|
|
| Uninterrupted apixaban | Drug | Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. |
|
|
| Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events |
Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. |
| Randomization to 1 month post catheter ablation |
Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. |
| Randomization to 1 month post catheter ablation |
| Number of Patients With Major Bleeding | Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. | Enrollment to 1 month post catheter ablation |
| Number of Patients With Thrombotic Events | Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. | Enrollment to 1 month post catheter ablation |
| Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events | Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. | Enrollment to 1 month post catheter ablation |
| Number of Patients With Composite of Major Bleeding and Thrombotic Events | Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher. | Enrollment to 1 month post catheter ablation |
| Number of Patients With TIAs or Non-Hemorrhagic Strokes | Number of Patients who had TIAs or non-hemorrhagic strokes. | Enrollment to 1 month post catheter ablation |
| Number of Patients With TIAs or Non-Hemorrhagic Strokes | This measurement includes TIAs or non-hemorrhagic strokes. | Randomization to 1 month post catheter ablation |
| Number of Patients With Death | Death is included in this measurement. | Enrollment to 1 month post catheter ablation |
| Number of Patients With Cardiovascular Death | Cardiovascular death is included in this measurement. | Enrollment to 1 month post catheter ablation |
| Number of Patients With Death | Death is included in this measurement. | Randomization to 1 month post catheter ablation |
| Number of Patients With Cardiovascular Death | Cardiovascular death is included in this measurement. | Randomization to 1 month post catheter ablation |
| Mission Viejo |
| California |
| 92690 |
| United States |
| Site 0012 | New Haven | Connecticut | 06501 | United States |
| Site 0011 | Trumbull | Connecticut | 06611 | United States |
| Site 0016 | Pensacola | Florida | 32501 | United States |
| Site 0014 | West Des Moines | Iowa | 50266 | United States |
| Site 0018 | Bangor | Maine | 04401 | United States |
| Site 0004 | Scarborough | Maine | 04074 | United States |
| Site 0008 | Boston | Massachusetts | 02118 | United States |
| Site 0001 | Burlington | Massachusetts | 01805 | United States |
| Site 0006 | Kansas City | Missouri | 64111 | United States |
| Site 0021 | Omaha | Nebraska | 68131 | United States |
| Site 0019 | Albuquerque | New Mexico | 87101 | United States |
| Site 0002 | Toledo | Ohio | 43615 | United States |
| Site 0007 | Oklahoma City | Oklahoma | 73104 | United States |
| Site 0009 | Philadelphia | Pennsylvania | 19019 | United States |
| Site 0010 | Charleston | South Carolina | 29401 | United States |
| Site 0017 | Austin | Texas | 78705 | United States |
| Site 0003 | Richmond | Virginia | 23219 | United States |
| Reynolds MR, Allison JS, Natale A, Weisberg IL, Ellenbogen KA, Richards M, Hsieh WH, Sutherland J, Cannon CP. A Prospective Randomized Trial of Apixaban Dosing During Atrial Fibrillation Ablation: The AEIOU Trial. JACC Clin Electrophysiol. 2018 May;4(5):580-588. doi: 10.1016/j.jacep.2017.11.005. Epub 2017 Dec 20. |
| FG001 | Uninterrupted Apixaban | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. |
|
| Safety | This number represents the safety population (analyzed under the actual treatment received). |
|
| COMPLETED | This represents the evaluable population (analyzed under assigned/randomized treatment). |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Interrupted Apixaban | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. |
| BG001 | Uninterrupted Apixaban | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | A total of 280 patients were evaluated for ethnicity measurement. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | A total of 283 patients were evaluated for race measurement. | Count of Participants | Participants | No |
| ||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| 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 Patients With Clinically-Significant Bleeding | Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. | Posted | Count of Participants | Participants | Randomization to 1 month post catheter ablation |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Patients With Thrombotic Events | Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. | Posted | Count of Participants | Participants | Randomization to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Composite of Major Bleeding and Thrombotic Events | Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. | Posted | Count of Participants | Participants | Randomization to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events | Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. | Posted | Count of Participants | Participants | Randomization to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Clinically-Significant Bleeding | Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. | Posted | Count of Participants | Participants | Enrollment to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Major Bleeding | Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. | Posted | Count of Participants | Participants | Randomization to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Major Bleeding | Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. | Posted | Count of Participants | Participants | Enrollment to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Thrombotic Events | Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. | Posted | Count of Participants | Participants | Enrollment to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events | Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher. | Posted | Count of Participants | Participants | Enrollment to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Composite of Major Bleeding and Thrombotic Events | Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher. | Posted | Count of Participants | Participants | Enrollment to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With TIAs or Non-Hemorrhagic Strokes | Number of Patients who had TIAs or non-hemorrhagic strokes. | Posted | Count of Participants | Participants | Enrollment to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With TIAs or Non-Hemorrhagic Strokes | This measurement includes TIAs or non-hemorrhagic strokes. | Posted | Count of Participants | Participants | Randomization to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Death | Death is included in this measurement. | Posted | Count of Participants | Participants | Enrollment to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Cardiovascular Death | Cardiovascular death is included in this measurement. | Posted | Count of Participants | Participants | Enrollment to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Death | Death is included in this measurement. | Posted | Count of Participants | Participants | Randomization to 1 month post catheter ablation |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Cardiovascular Death | Cardiovascular death is included in this measurement. | Posted | Count of Participants | Participants | Randomization to 1 month post catheter ablation |
|
1 Month
Treatment Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and Preferred Term. The safety population was used to report the SAEs and AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interrupted Apixaban | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Interrupted apixaban: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. A total of 149 patients were included in the "Interrupted Apixaban" arm from the safety population (patients were analyzed under the actual treatment received). | 0 | 149 | 14 | 149 | 72 | 149 |
| EG001 | Uninterrupted Apixaban | Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. Uninterrupted apixaban: Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration. A total of 151 patients were included in the "Uninterrupted Apixaban" arm from the safety population (patients were analyzed under the actual treatment received). | 0 | 151 | 15 | 151 | 75 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia Supraventricular | Cardiac disorders | Systematic Assessment |
| ||
| Blindness Transient | Eye disorders | Systematic Assessment |
| ||
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Catheter Site Haemorrhage | General disorders | Systematic Assessment |
| ||
| Pneumonia Mycoplasmal | Infections and infestations | Systematic Assessment |
| ||
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fluid Overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fistula | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Perforation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
| ||
| Sinus Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Catheter Site Pain | General disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Hypervolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngeal Haemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Spontaneous haemorrhage | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia supraventricular | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial thrombosis | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block first degree | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac perforation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Diastolic dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Sinus arrest | Cardiac disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Middle ear effusion | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Blindness transient | Eye disorders | Systematic Assessment |
| ||
| Eye irritation | Eye disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Visual impairment | Eye disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dental caries | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lip swelling | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mouth haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Catheter site bruise | General disorders | Systematic Assessment |
| ||
| Catheter site discharge | General disorders | Systematic Assessment |
| ||
| Catheter site haematoma | General disorders | Systematic Assessment |
| ||
| Catheter site haemorrhage | General disorders | Systematic Assessment |
| ||
| Catheter site pain | General disorders | Systematic Assessment |
| ||
| Catheter site swelling | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Infusion site pain | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Catheter site infection | Infections and infestations | Systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Incision site infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia mycoplasmal | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Cardiac procedure complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Periorbital haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural headache | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural nausea | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural vomiting | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Electrocardiogram QT prolonged | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| International normalised ratio increased | Investigations | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid retention | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypervolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fistula | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Haemorrhage urinary tract | Renal and urinary disorders | Systematic Assessment |
| ||
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Gynaecomastia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Aortic stenosis | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Trial Design and Development | Baim Institute for Clinical Research | 617-307-5200 | TrialDesignandDevelopmentStaff@baiminstitute.org |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 2, 2015 | Jan 30, 2020 | Prot_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 |
Not provided
Not provided
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