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| Name | Class |
|---|---|
| IHF GmbH - Institut für Herzinfarktforschung | OTHER |
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Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient population with atrial fibrillation (AF) and evaluate its performance.
Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.
This registry will collect data prospectively on patients with paroxysmal, persistent and longstanding persistent atrial fibrillation (hereafter "AF") undergoing Phased RFA treatment. Phased RFA will be applied according to the 'Intended Use' in CE mark (European Conformity) release and product packaging.
The treatment will be performed according to routine hospital practice and no additional tests are required specific to the registry. This registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, effectiveness and functionality of the Medtronic Phased RFA System in a real world patient population.
The key measures collected for the patients will be inclusive of, but are not limited to, clinical data pertaining to AF and individual disease state(s) characterized by form of AF and underline diseases, Phased RFA procedure details including timing and catheters in use, procedure and system related adverse events, AF recurrence, re-ablations and left atrial flutter rate after the index Phased RFA procedure. Additionally, this study will provide further information in the evolving anticoagulation strategies (e.g. continuous versus bridging and vitamin K antagonist versus novel oral anticoagulants) in the setting of AF ablations. Patients will be followed minimum for 12 months and maximum for 14 months after the Phased RFA ablation procedure. The twelve month follow-up can be done by telephone if it is not standard of care in the hospital's practice. During the twelve month follow-up patients will be interviewed with a quality of life questionnaire and results will be compared to the quality of life questionaire completed before the procedure.
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| Measure | Description | Time Frame |
|---|---|---|
| Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate | Success rate will be estimated as time to first event: AF recurrence and/or left Atrial Flutter. Parameters of interest include: re-ablations, ECG/EGM (electrogram) recorded AF, electrical and pharmacological cardioversions. | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate Phased RFA Mid-term Safety | Estimate major procedure/system related complications of Phased RFA | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Success Rate | Procedure considered successful if all PVs (pulmonary veins) were isolated (entrance and/or exit block confirmation per vein) and procedure was not declined due to technical issues related to Phased RFA system | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
Inclusion criteria:
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Eligible are all patients with paroxysmal, persistent and long-standing persistent AF who fulfill all inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Lucas Boersma, MD, Ph.D | St. Antonious | Principal Investigator |
| Meleze Hocini, MD | Hôpital Cardiologique du Haut-Lévêque | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| CHU de Bordeaux |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phased RFA System | Observation study / registry with one patient group. Data on the use of the Phased AF system in the "real world" clinical practice / daily routine of EP (electrophysiology) laboratories utilizing the Phased AF system was collected. |
| 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 | Aug 25, 2016 | Sep 27, 2019 |
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| Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time | Parameters to measure the efficiency: procedure duration, laboratory occupancy duration, fluoroscopy time | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
| Peri-procedural Anticoagulation Therapy - Activated Clotting Time | Characterize anticoagulation therapy: activated clotting time (ACT) during the procedure. Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
| Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used | Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
| Quality of Life Dynamic - AFEQT Score at 12 Months | Quality of life will be captured using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. It is a standardized, disease-specific, reliable and responsive measure of health-related quality of life in subjects with AF. The AFEQT is a self-reported questionnaire with responses on a 7-point Likert scale. The 20-item instrument is divided into three domains (4-item symptom score, 8-item daily activities score, 6-item treatment concerns score) plus two treatment satisfaction questions.In countries where no validated version is available yet (e.g. Israel, Portugal), the AFEQT questionnaire will not be applied or will be additionally validated for the country official languages according to local requirements and regulations. Overall or subscale range from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability). | Patient will be followed for minimum 12 months, maximum 14 months, 12 month reported |
| Procedural Efficiency - Number of Catheters Used | Parameters to measure the efficiency: Phased RFA consumables used | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
| Procedural Efficiency - Number of Adjunctive Devices Used | Parameters to measure the efficiency: adjunctive devices used | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
| Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR) | Characterize anticoagulation therapy: international normalized ratio (INR). Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. INR can be used to assess the risk of bleeding or the coagulation status of the patients. | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
| Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy | Characterize anticoagulation therapy: utilization of vitamin K antagonists (VKA), novel oral anticoagulants (NOAC), peri -procedural "bridging" vs "no bridging" strategy. Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
| Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions | Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
| Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Persistent AF Participants With Cardioversions for AF Within Last 12 Months | Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
| Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure | Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
| Bordeaux |
| France |
| CMC Parly 2 | Le Chesnay | 78150 | France |
| Centre Cardiologique du Nord | Saint-Denis | France |
| Jo Ann Medical Center | Tbilisi | Georgia |
| St. Johannes Hospital | Dortmund | Germany |
| Evangelisches Krankenhaus | Düsseldorf | Germany |
| Helios Klinikum Erfurt | Erfurt | Germany |
| Herz- und Gefäßzentrum Oberallgäu-Kempten | Kempten | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| St. Vincenz-Krankenhaus Paderborn | Paderborn | Germany |
| General Hospital Alexandra | Athens | Greece |
| Military Hospital | Budapest | Hungary |
| University of Debrecen | Debrecen | Hungary |
| The Barzilai Medical Center Ashkleon | Ashkelon | Israel |
| Soroka University Medical Center | Beersheba | Israel |
| Hadassah Medical Center | Jerusalem | Israel |
| Kaplan Medical Center | Rehovot | Israel |
| A.O. Papa Giovanni XXIII | Bergamo | Italy |
| Az. Osped. Pugliese Ciaccio | Catanzaro | Italy |
| Ospedale Mater Salutis | Legnago | Italy |
| A.O. Osped. S.Gerardo | Monza | Italy |
| A.O. San Camillo Forlanini | Rome | Italy |
| Medisch Centrum Leeuwarden B.V. | Leeuwarden | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 | Lublin | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 2 | Szczecin | Poland |
| Samodzielny Publiczny Centralny Szpital Kliniczny | Warsaw | Poland |
| 4 Wojskowy Szpital Kliniczny | Wroclaw | Poland |
| Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E. | Lisbon | Portugal |
| Sejong General Hospital | Bucheon-si | South Korea |
| Keimyung University Dongsan Hospital | Daegu | South Korea |
| Yeungnam University Hospital | Daegu | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Hospital Donostia | Donostia / San Sebastian | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hirslanden Klinik St. Anna AG | Zurich | Switzerland |
| Eastbourne District General Hospital | Eastbourne | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phased RFA System | Observation study / registry with one patient group. Data on the use of the Phased AF system in the "real world" clinical practice / daily routine of EP laboratories utilizing the Phased AF system was collected. |
| 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 |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body-Mass-Index (BMI) | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||||
| Atrial Fibrillation (AF) Status | Count of Participants | Participants |
| ||||||||||||||||||
| Symptomatic Atrial Fibrillation | Count of Participants | 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 | Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate | Success rate will be estimated as time to first event: AF recurrence and/or left Atrial Flutter. Parameters of interest include: re-ablations, ECG/EGM (electrogram) recorded AF, electrical and pharmacological cardioversions. | Posted | Mean | Standard Deviation | Days | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
|
|
| ||||||||||||||||||||||||||
| Secondary | Estimate Phased RFA Mid-term Safety | Estimate major procedure/system related complications of Phased RFA | Posted | Number | events | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Acute Procedural Success Rate | Procedure considered successful if all PVs (pulmonary veins) were isolated (entrance and/or exit block confirmation per vein) and procedure was not declined due to technical issues related to Phased RFA system | Posted | Number | % of procedural success rate | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time | Parameters to measure the efficiency: procedure duration, laboratory occupancy duration, fluoroscopy time | Posted | Mean | Standard Deviation | Minutes | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Peri-procedural Anticoagulation Therapy - Activated Clotting Time | Characterize anticoagulation therapy: activated clotting time (ACT) during the procedure. Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding | Posted | Mean | Standard Deviation | seconds | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used | Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group | Patients with persistent AF only | Posted | Mean | Standard Deviation | catheter | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Quality of Life Dynamic - AFEQT Score at 12 Months | Quality of life will be captured using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. It is a standardized, disease-specific, reliable and responsive measure of health-related quality of life in subjects with AF. The AFEQT is a self-reported questionnaire with responses on a 7-point Likert scale. The 20-item instrument is divided into three domains (4-item symptom score, 8-item daily activities score, 6-item treatment concerns score) plus two treatment satisfaction questions.In countries where no validated version is available yet (e.g. Israel, Portugal), the AFEQT questionnaire will not be applied or will be additionally validated for the country official languages according to local requirements and regulations. Overall or subscale range from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability). | 911 patients filled in validated language versions of the AFEQT; 143 patients filled in not validated language versions; AFEQT score at baseline available for 954 patients. The response on the AFEQT are scored on a 1 to 7 Likert scale, 1 = "not at all" to 7 = "Extremely". | Posted | Mean | Standard Deviation | score on a scale | Patient will be followed for minimum 12 months, maximum 14 months, 12 month reported |
| |||||||||||||||||||||||||||
| Other Pre-specified | Procedural Efficiency - Number of Catheters Used | Parameters to measure the efficiency: Phased RFA consumables used | Posted | Mean | Standard Deviation | catheters | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration | procedures | procedures |
|
| |||||||||||||||||||||||||
| Other Pre-specified | Procedural Efficiency - Number of Adjunctive Devices Used | Parameters to measure the efficiency: adjunctive devices used | Posted | Number | procedures | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration | procedures | procedures |
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| Other Pre-specified | Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR) | Characterize anticoagulation therapy: international normalized ratio (INR). Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. INR can be used to assess the risk of bleeding or the coagulation status of the patients. | Posted | Mean | Standard Deviation | ratio | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy | Characterize anticoagulation therapy: utilization of vitamin K antagonists (VKA), novel oral anticoagulants (NOAC), peri -procedural "bridging" vs "no bridging" strategy. Correlate anticoagulation therapy with thromboembolic events and bleeding the peri -procedural thromboembolic events and bleeding | Posted | Number | percentage of patients | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions | Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group | Patients with persistent AF only | Posted | Mean | Standard Deviation | cardioversions | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Persistent AF Participants With Cardioversions for AF Within Last 12 Months | Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group | Patients with persistent AF only | Posted | Number | percentage of persistent AF patients | Patient will be followed in the Catheterization Laboratory (hereafter "CathLab")/operating room during approximately 2 hours of Phased RFA procedure duration |
|
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| Other Pre-specified | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure | Evaluate which tools participating centers use (MAAC (Multi-Array Ablation Catheter) and/or MASC (Multi-Array Septal Catheter) and/or PVAC GOLD) in persistent and long standing persistent AF and to verify patient's characteristics, procedure approaches and estimates outcome across participating sites. The main interest is if PVAC GOLD catheter can be utilized as a single catheter for patients with persistent AF and analyze AF recurrence rate in this group | Persistent AF patients only | Posted | Number | percentage of patient procedures | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA |
|
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Adverse Events (AEs) including their relatedness to the respective procedure, were documented starting from the first documented procedure until the 12-month FU (follow-up). Analysis was performed at 30 days and 12 months after procedure.
For the analysis, only adjudicated Adverse Event (AE) data and coded AE data (from free text fields) were used. In addition, TIA (transient ischaemic attack)/stroke events were taken from from the general follow-up forms to calculate procedure safety.
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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 | Phased RFA System | Observation study / registry with one patient group. Data on the use of the Phased AF system in the "real world" clinical practice / daily routine of EP laboratories utilizing the Phased AF system was collected. | 4 | 1,071 | 42 | 1,071 | 63 | 1,071 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | General disorders | Non-systematic Assessment |
| ||
| Vascular access complication | General disorders | Non-systematic Assessment |
| ||
| Other diagnosis | General disorders | Non-systematic Assessment | Classified as other |
| |
| Stroke | General disorders | Non-systematic Assessment |
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| Left Atrial Fibrillation | General disorders | Non-systematic Assessment |
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| Acute Coronary Syndrome | General disorders | Non-systematic Assessment |
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| Phrenic Nerve Damage | General disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular Access Complication | General disorders | Non-systematic Assessment |
| ||
| Other (diagnosis) | General disorders | Non-systematic Assessment | Other |
| |
| Left Atrial Fibrillation | General disorders | Non-systematic Assessment |
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| Acute Coronary Syndrome | General disorders | Non-systematic Assessment |
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| Pulmonary Vein (PV) Stenosis | General disorders | Non-systematic Assessment |
| ||
| Transient Ischaemic Attack (TIA) | General disorders | Non-systematic Assessment |
| ||
| Bleeding | General disorders | Non-systematic Assessment |
|
Details are described in the project specific Publication Plan.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ralf Meyer | Medtronic GmbH | 01755810431 | ralf.meyer@medtronic.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2018 | Sep 18, 2019 | SAP_000.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 |
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| Portugal |
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| Switzerland |
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| Spain |
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| Greece |
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| Netherlands |
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| South Korea |
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| Poland |
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| Italy |
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| Israel |
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| Georgia |
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| France |
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| Germany |
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| Longstanding persistent Atrial Fibrillation |
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