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The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.
The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) trial being performed at multiple centers in the United States, Canada and Europe to evaluate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of patients with persistent atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation | Device | A procedure will be performed using a radiofrequency ablation catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Events | Participant count of a composite of safety events including: serious adverse events (SAEs), procedure and/or device-related significant pericardial effusion, severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula | Ablation through 6 months |
| Primary Effectiveness | The primary effectiveness endpoint is defined as freedom from documented AF, Atrial Flutter, (AFL) and Atrial Tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From a Composite of Serious Adverse Events (SAEs) | Freedom from a composite of SAEs occurring within 30-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. | Within 30-days post-index ablation |
| Freedom From Documented AF/AFL/AT Episodes |
| Measure | Description | Time Frame |
|---|---|---|
| Total Procedure Time (Minutes) | Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed. | Immediately after the index ablation procedure |
| Total Treatment Device Time (Minutes) |
Inclusion Criteria:
Exclusion Criteria:
At time of enrollment and/or prior to procedure:
Continuous AF >12 months (long-standing persistent AF)
Paroxysmal AF with longest episode <7 days
AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
Rheumatic heart disease
Severe mitral regurgitation
Hypertrophic cardiomyopathy
LA diameter >5.5 cm
Left ventricular ejection fraction (LVEF) <40%
Currently NYHA Class III or IV or exhibits uncontrolled heart failure
Body Mass Index (BMI) >42 kg/m2.
LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment
Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation
Coagulopathy, bleeding diathesis or suspected procoagulant state
Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) within a week prior to the ablation procedure
Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
Life expectancy <12 months based on medical history or the medical judgement of the investigator.
Within 1 month of enrollment or just prior to procedure:
Documented LA thrombus upon imaging
Creatinine >2.5mg/dl or creatinine clearance <30mL/min
Within 3 months of enrollment:
Significant gastrointestinal (GI) bleed
Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention
Within 6 months of enrollment:
Coronary artery bypass graft (CABG) procedure
Implant procedure performed for ICD, CRT leads or pacemaker
Documented stroke, CVA, TIA or suspected neurological event
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| Name | Affiliation | Role |
|---|---|---|
| Atul Verma, MD | Medical Director, Heart Rhythm Program, Southlake Regional Health Centre | Principal Investigator |
| Andrea Natale, MD | Director, Electrophysiology, Texas Cardiac Arrhythmia Institute at St. David's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35242 | United States | ||
| University Of Alabama |
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Of the 376 subjects enrolled, 15 exited the study prior to undergoing ablation and were not included in the intent-to-treat (ITT) population. These subjects may have exited for various reasons including withdrawal of consent or clinical exclusion criteria discovered after enrollment. Baseline assessments were conducted prior to ablation to confirm eligibility and ensure protocol compliance.
Recruitment for the study occurred from September 2018 to November 2023. The first subject was enrolled on September 19, 2018, and the last patient visit occurred on October 31, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled subjects | All enrolled subjects underwent catheter ablation using the DiamondTemp™ Ablation (DTA) system. A total of 376 subjects were enrolled. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2021 | May 30, 2025 |
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Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period lasting ≥ 30 seconds in duration by ECG monitoring. |
| Within 3 months |
| Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy. | Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy. | Within 3 months |
| Acute Procedural Success | Participant count of acute procedural success, defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV | Day of index ablation procedure |
| Single Procedure Success With Freedom From AF/AT/AFL | Participant count of single procedure success defined as the rate of subjects treated with one single ablation procedure for the entire enrollment period and with freedom from documented symptomatic AF, AT and AFL* at 12 months. | 12 months after the index ablation procedure |
| Single Procedure Success With Freedom From All Primary Effectiveness Failures | Participant count of single procedure success with freedom from all primary effectiveness failure criteria. | 12 months |
| AFEQT Quality of Life, Baseline | QOL using the AFEQT Questionnaire, baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. | Day of index ablation procedure |
| AFEQT Quality of Life, 6-month Follow-up | QOL using the AFEQT Questionnaire, 6 month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. | 6 months after index ablation procedure |
| AFEQT Quality of Life, 12-month Follow up | QOL using the AFEQT Questionnaire, 12-month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. | 12 months after index ablation procedure |
| Change in AFEQT Quality of Life From Baseline to 12-month | Changes in QOL using the AFEQT Questionnaire between 12-month and baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. | Index ablation procedure through 12 months |
| National Institutes of Health Stroke Scale, Pre-discharge | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. | Day of index ablation procedure |
| National Institutes of Health Stroke Scale, One- Month Follow up | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. | One month after index ablation procedure |
| National Institutes of Health Stroke Scale, 12-month Follow-up | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. | 12 months after the index ablation procedure |
Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter. |
| Day of index ablation procedure |
| Cumulative RF Time | Mean cumulative RF Time (minutes). | Day of index ablation procedure |
| Duration of RF Ablations (Seconds) | Mean duration of RF ablations (seconds) | Day of index ablation procedure |
| Fluid Infused Through the Investigational Catheter (mL) | Total fluid infused through the investigational catheter (mL) | Day of index ablation procedure |
| Fluoroscopy Time (Minutes) | Total fluoroscopy exposure time (minutes) | Day of index ablation procedure |
| Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence. | Number of subjects who were re-hospitalized due to atrial fibrillation recurrence after blanking period. | Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Keck School Of Medicine | Los Angeles | California | 90033 | United States |
| Advent Health, Florida Hospital Orlando | Orlando | Florida | 32751 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Montefiore Medical Center | New York | New York | 10467 | United States |
| Trident Medical Center | Charleston | South Carolina | 29406 | United States |
| Medical University Of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Southlake Regional Health Center | Newmarket | Ontario | L3Y2P6 | Canada |
| Montreal Heart Institute | Montreal | Quebec | HITC8 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) | Québec | Quebec | G1V4G5 | Canada |
| Institut Klinicke a Experimentalni Mediciny (IKEM) | Prague | Czechia | 14021 | Czechia |
| Na Homolce | Prague | Prague | 15000 | Czechia |
| St Ann's University Hospital | Brno | 65691 | Czechia |
| Clinique du Tonkin | Villeurbanne | Lyon | 69100 | France |
| CHRU Nancy | Nancy | 54511 | France |
| Clinique Saint Pierre | Perpignan | 66000 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| Leipzig Heart Institute GmbH | Leipzig | 04289 | Germany |
| Centro Cardiologico Monzino | Milan | Milano | 20138 | Italy |
| Ospedale dell'Angelo | Venezia | 30174 | Italy |
| Intention-to-treat (ITT) | Of all enrolled subjects, 361 subjects underwent an ablation, forming the ITT cohort. |
|
| Modified intention-to-treat (MITT) | The mITT population (n=290) included subjects who met all eligibility criteria and were ablated. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Intention-to-treat (mITT) Cohort | All enrolled subjects underwent catheter ablation using the DiamondTemp™ Ablation (DTA) system. A total of 376 subjects were enrolled. Of these, 361 subjects underwent ablation and formed the intent-to-treat (ITT) population. Following ablation, subjects were followed for 12 months to assess safety and effectiveness outcomes. The mITT population (n=290) included subjects who met all eligibility criteria and were ablated. Subjects not meeting all eligibility criteria (n=71) were still followed as part of a secondary analysis. The follow-up protocol included scheduled assessments and monitoring at predetermined time points up to 12 months post-ablation. Exit reasons included voluntary withdrawal, death, or loss to follow-up. |
| 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) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | Primary Safety Events | Participant count of a composite of safety events including: serious adverse events (SAEs), procedure and/or device-related significant pericardial effusion, severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula | Posted | Number | participants | Ablation through 6 months |
|
|
| |||||||||||||||||||||||||||
| Primary | Primary Effectiveness | The primary effectiveness endpoint is defined as freedom from documented AF, Atrial Flutter, (AFL) and Atrial Tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). | Posted | Number | participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Freedom From a Composite of Serious Adverse Events (SAEs) | Freedom from a composite of SAEs occurring within 30-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. | Posted | Number | participants | Within 30-days post-index ablation |
|
| ||||||||||||||||||||||||||||
| Secondary | Freedom From Documented AF/AFL/AT Episodes | Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period lasting ≥ 30 seconds in duration by ECG monitoring. | Posted | Number | participants | Within 3 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy. | Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy. | Posted | Number | participants | Within 3 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Acute Procedural Success | Participant count of acute procedural success, defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV | Posted | Number | participants | Day of index ablation procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | Single Procedure Success With Freedom From AF/AT/AFL | Participant count of single procedure success defined as the rate of subjects treated with one single ablation procedure for the entire enrollment period and with freedom from documented symptomatic AF, AT and AFL* at 12 months. | Posted | Number | participants | 12 months after the index ablation procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | Single Procedure Success With Freedom From All Primary Effectiveness Failures | Participant count of single procedure success with freedom from all primary effectiveness failure criteria. | Posted | Number | participants | 12 months |
|
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| Secondary | AFEQT Quality of Life, Baseline | QOL using the AFEQT Questionnaire, baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. | Posted | Mean | 95% Confidence Interval | score on a scale | Day of index ablation procedure |
|
| |||||||||||||||||||||||||||
| Secondary | AFEQT Quality of Life, 6-month Follow-up | QOL using the AFEQT Questionnaire, 6 month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 months after index ablation procedure |
|
| |||||||||||||||||||||||||||
| Secondary | AFEQT Quality of Life, 12-month Follow up | QOL using the AFEQT Questionnaire, 12-month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after index ablation procedure |
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| |||||||||||||||||||||||||||
| Secondary | Change in AFEQT Quality of Life From Baseline to 12-month | Changes in QOL using the AFEQT Questionnaire between 12-month and baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. | Posted | Mean | 95% Confidence Interval | score on a scale | Index ablation procedure through 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | National Institutes of Health Stroke Scale, Pre-discharge | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. | Posted | Count of Participants | Participants | Day of index ablation procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | National Institutes of Health Stroke Scale, One- Month Follow up | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. | Posted | Count of Participants | Participants | One month after index ablation procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | National Institutes of Health Stroke Scale, 12-month Follow-up | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. | Posted | Count of Participants | Participants | 12 months after the index ablation procedure |
|
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| Other Pre-specified | Total Procedure Time (Minutes) | Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed. | Posted | Mean | Standard Deviation | minutes | Immediately after the index ablation procedure |
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| Other Pre-specified | Total Treatment Device Time (Minutes) | Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter. | Posted | Mean | Standard Deviation | minutes | Day of index ablation procedure |
|
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| Other Pre-specified | Cumulative RF Time | Mean cumulative RF Time (minutes). | Posted | Mean | Standard Deviation | minutes | Day of index ablation procedure |
|
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| Other Pre-specified | Duration of RF Ablations (Seconds) | Mean duration of RF ablations (seconds) | Posted | Mean | Standard Deviation | seconds | Day of index ablation procedure |
|
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| Other Pre-specified | Fluid Infused Through the Investigational Catheter (mL) | Total fluid infused through the investigational catheter (mL) | Posted | Mean | Standard Deviation | mL | Day of index ablation procedure |
|
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| Other Pre-specified | Fluoroscopy Time (Minutes) | Total fluoroscopy exposure time (minutes) | Posted | Mean | Standard Deviation | minutes | Day of index ablation procedure |
|
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| Other Pre-specified | Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence. | Number of subjects who were re-hospitalized due to atrial fibrillation recurrence after blanking period. | Posted | Count of Participants | Participants | Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). |
|
|
From index ablation procedure through 12 months of follow-up.
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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 | Intention-to-treat (ITT) | There were 376 subjects enrolled in the study. Of these, 361 (96.0%) underwent an ablation, while 15 exited without undergoing ablation. | 2 | 361 | 78 | 361 | 22 | 361 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Angina unstable | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure acute | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Cardiovascular disorder | Cardiac disorders | Systematic Assessment |
| ||
| Conduction disorder | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Right ventricular failure | Cardiac disorders | Systematic Assessment |
| ||
| Sinus arrest | Cardiac disorders | Systematic Assessment |
| ||
| Sinus node dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Visual impairment | Eye disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Implant site extravasation | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Systemic inflammatory response syndrome | General disorders | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Graft infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Post procedural pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pulmonary sepsis | Infections and infestations | Systematic Assessment |
| ||
| Streptococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Cardiac procedure complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Multiple injuries | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural stroke | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Exostosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Migraine with aura | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Device pacing issue | Product Issues | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Hallucination, auditory | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal colic | Renal and urinary disorders | Systematic Assessment |
| ||
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemorrhoid operation | Surgical and medical procedures | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypertensive crisis | Vascular disorders | Systematic Assessment |
| ||
| Hypertensive urgency | Vascular disorders | Systematic Assessment |
| ||
| Vasculitis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josman Suri | Medtronic CAS | 7635050262 | josman.suri@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2021 | May 30, 2025 | SAP_001.pdf |
Not provided
| 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 |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Unknown or Not Reported |
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| Caucasian (European descent) |
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| Unknown |
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| Other |
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