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The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
Patients undergoing successful cardiac ablation for atrial fibrillation who remain AF recurrence-free 3 months after successful ablation and continue to meet the inclusion/exclusion criteria will be screened for enrollment in the trial. After fulfilling all of the inclusion/exclusion criteria, patients who consent to participate in the study and remain AF recurrence-free will be randomized to one of two study arms: (1) OAT Withdrawal (Test) Group or (2) OAT (Control) Group and participate in the Evaluation Period (12 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Off OAT Group (Test) | Experimental | Discontinuation of OAT Therapy |
|
| On OAT Group (Control) | Other | Continuation of OAT Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Off OAT Group (Test) | Other | Discontinuation of OAT Therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Occurrence of Any Major Thromboembolic Event | Composite endpoint represented by the occurrence of any major thromboembolic event (stroke [i.e., ischemic, hemorrhagic or cryptogenic] that is an acute onset of a focal neurologic deficit of presumed vascular origin lasting for ≥24 hours or resulting in death) or major hemorrhagic complication (major bleeding) during the 12-month Evaluation Period. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Minor Bleeds | Any clinical bleed that does not meet criteria for a major hemorrhagic event during the 12-month Evaluation Period. | 12 months |
| Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Antonio Raviele, MD | Dell'Angelo Hospital | Principal Investigator |
| Michael Riley, MD | University of Pennsylvania | Principal Investigator |
| Karl Heinz Kuck, MD | Hanseatisches Herzzentrum, Asklepios Klinik | Principal Investigator |
| Michel Haissaguerre, MD | Hospital Cardiologigue du Haut-Leveque | Principal Investigator |
| Pierre Jais, MD | Hospital Cardiologigue du Haut-Leveque | Principal Investigator |
| Sakis Themistoclakis, MD | Dell'Angelo Hospital | Principal Investigator |
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This was a prospective, multicenter, randomized, controlled, two arm, 1:1 design. Enrolled subjects N=80 (subjects signed informed consent). 63 subjects underwent study procedures, 17 subjects were excluded prior to randomization. According to protocol, enrolled subjects = subjects who sign the study's informed consent form.
The first subject was enrolled April 17, 2013. The last subject was enrolled January 25, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Off OAT Group (Test) | Discontinuation of OAT Therapy |
| FG001 | On OAT Group (Control) | Continuation of OAT Therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Off OAT Group (Test) | Discontinuation of OAT Therapy |
| BG001 | On OAT Group (Control) | Continuation of OAT 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 | Number of Participants With Occurrence of Any Major Thromboembolic Event | Composite endpoint represented by the occurrence of any major thromboembolic event (stroke [i.e., ischemic, hemorrhagic or cryptogenic] that is an acute onset of a focal neurologic deficit of presumed vascular origin lasting for ≥24 hours or resulting in death) or major hemorrhagic complication (major bleeding) during the 12-month Evaluation Period. | Posted | Number | Number of Participants | 12 months |
|
12 Months
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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 | Off OAT Group (Test) | Discontinuation of OAT Therapy | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Lyke | Biosense Webster Inc. | (949) 285-7966 | SLyke@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2013 | Nov 20, 2020 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| On OAT Group (Control) |
| Other |
Continuation of OAT Therapy |
|
Hospitalization due to any thromboembolic or major hemorrhagic event during the 12-month Evaluation Period. |
| 12 months |
| Percentage of Expired Participants | All cause mortality during the 12-month Evaluation Period. | 12 months |
| Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS) | The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability. | Baseline, 3 months, 12 months |
| Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS) | The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability. | Baseline, 3 months, 12 months |
| Percentage of Participants With Atrial Fibrillation Recurrence | Recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects with recurrence of atrial fibrillation were immediately exited from the study. | 12 months |
| Percentage of Participants With Repeat Ablation | Repeat ablations performed due to recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects that required a repeat ablation were immediately exited from the study. | 12 months |
| Discontinued Subjects |
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Percentage of Participants With Minor Bleeds | Any clinical bleed that does not meet criteria for a major hemorrhagic event during the 12-month Evaluation Period. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
|
|
| Secondary | Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event | Hospitalization due to any thromboembolic or major hemorrhagic event during the 12-month Evaluation Period. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
|
|
| Secondary | Percentage of Expired Participants | All cause mortality during the 12-month Evaluation Period. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
|
|
| Secondary | Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS) | The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability. | The number of participants analyzed at each time point reflects the number of surveys collected at that time point for each group. Participants may have refused to complete the survey, or were exited from the study prior to the visit. | Posted | Mean | Standard Deviation | Points on SF-36 scale | Baseline, 3 months, 12 months |
|
|
|
| Secondary | Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS) | The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability. | The number of participants analyzed at each time point reflects the number of surveys collected at that time point for each group. Participants may have refused to complete the survey, or were exited from the study prior to the visit. | Posted | Mean | Standard Deviation | Points on SF-36 scale | Baseline, 3 months, 12 months |
|
|
|
| Secondary | Percentage of Participants With Atrial Fibrillation Recurrence | Recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects with recurrence of atrial fibrillation were immediately exited from the study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
|
|
| Secondary | Percentage of Participants With Repeat Ablation | Repeat ablations performed due to recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects that required a repeat ablation were immediately exited from the study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
|
|
| 32 |
| 6 |
| 32 |
| 0 |
| 32 |
| EG001 | On OAT Group (Control) | Continuation of OAT Therapy | 0 | 31 | 2 | 31 | 4 | 31 |
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Arterial bypass thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vocal cord paralysis | Nervous system disorders | Systematic Assessment |
|
| Joint Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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Any results communications proposed to be published or presented shall be submitted to Sponsor at least 60 days prior to public release to permit Sponsor to direct removal of any confidential information contained therein. The first results communications should be a multicenter, joint publication. If a multicenter publication is not submitted by the Sponsor or designee within 12 months of the Study conclusion, PIs may publish results from their institution in accordance with the above.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Mean Score at 3 Months |
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| Mean Score at 12 Months |
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| Mean Score at 3 Months |
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| Mean Score at 12 Months |
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