Atrial Fibrillation
Conditions
Keywords
Pulmonary Vein Isolation, Phased Radiofrequency Ablation
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
IHF GmbH - Institut für Herzinfarktforschung
Medtronic Cardiac Ablation Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with AF who is scheduled for Phased RFA procedure * Patient signed patient informed consent or patient data release form * Age ≥18 years old To avoid enrollment bias in this cohort of patient and reflect real world clinical practice for Phased RFA no
Exclusion criteria
will be defined.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate Phased RFA Mid-term Safety | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA | Estimate major procedure/system related complications of Phased RFA |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peri-procedural Anticoagulation Therapy - Activated Clotting Time | Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration | 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 |
| Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA | 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 |
| Quality of Life Dynamic - AFEQT Score at 12 Months | Patient will be followed for minimum 12 months, maximum 14 months, 12 month reported | 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). |
| Procedural Efficiency - Number of Catheters Used | Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration | Parameters to measure the efficiency: Phased RFA consumables used |
| Procedural Efficiency - Number of Adjunctive Devices Used | Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration | Parameters to measure the efficiency: adjunctive devices used |
| Acute Procedural Success Rate | Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration | 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 |
| Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy | Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration | 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 |
| Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA | 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 |
| 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 | Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration | 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 |
| Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA | 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 |
| Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR) | Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration | 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. |
| Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time | Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration | Parameters to measure the efficiency: procedure duration, laboratory occupancy duration, fluoroscopy time |
Countries
France, Georgia, Germany, Greece, Hungary, Israel, Italy, Netherlands, Poland, Portugal, South Korea, Spain, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,054 |
| Total | 1,054 |
Baseline characteristics
| Characteristic | Phased RFA System | — |
|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 10.9 | — |
| Atrial Fibrillation (AF) Status Longstanding persistent Atrial Fibrillation | 35 Participants | — |
| Atrial Fibrillation (AF) Status Paroxysmal Atrial Fibrillation (PAF) | 740 Participants | — |
| Atrial Fibrillation (AF) Status Persistent Atrial Fibrillation | 279 Participants | — |
| Body-Mass-Index (BMI) | 27.8 kg/m2 STANDARD_DEVIATION 4.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 42 participants | — |
| Region of Enrollment Georgia | 2 participants | — |
| Region of Enrollment Germany | 213 participants | — |
| Region of Enrollment Greece | 9 participants | — |
| Region of Enrollment Hungary | 37 participants | — |
| Region of Enrollment Israel | 40 participants | — |
| Region of Enrollment Italy | 182 participants | — |
| Region of Enrollment Netherlands | 181 participants | — |
| Region of Enrollment Poland | 123 participants | — |
| Region of Enrollment Portugal | 57 participants | — |
| Region of Enrollment South Korea | 73 participants | — |
| Region of Enrollment Spain | 73 participants | — |
| Region of Enrollment Switzerland | 33 participants | — |
| Region of Enrollment United Kingdom | 6 participants | — |
| Sex: Female, Male Female | 341 Participants | — |
| Sex: Female, Male Male | 713 Participants | — |
| Symptomatic Atrial Fibrillation | 1007 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 1,071 |
| other Total, other adverse events | 63 / 1,071 |
| serious Total, serious adverse events | 42 / 1,071 |
Outcome results
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.
Time frame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phased RFA System | Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate | 185.1 Days | Standard Deviation 76.6 |
Secondary
Estimate Phased RFA Mid-term Safety
Estimate major procedure/system related complications of Phased RFA
Time frame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phased RFA System | Estimate Phased RFA Mid-term Safety | 27 events |
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
Time frame: Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phased RFA System | Acute Procedural Success Rate | 94.3 % of procedural success rate |
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
Time frame: Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phased RFA System | Peri-procedural Anticoagulation Therapy - Activated Clotting Time | Lowest ACT | 274.4 seconds | Standard Deviation 95.3 |
| Phased RFA System | Peri-procedural Anticoagulation Therapy - Activated Clotting Time | Highest activated clotting time (ACT) | 356.9 seconds | Standard Deviation 115.7 |
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.
Time frame: Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phased RFA System | Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR) | 1.4 ratio | Standard Deviation 0.6 |
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
Time frame: Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phased RFA System | Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy | Oral anticoagulants discontinued before procedure | 53.8 percentage of patients |
| Phased RFA System | Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy | Previously treated with VKA | 23.2 percentage of patients |
| Phased RFA System | Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy | Previously treated with NOACs | 63.5 percentage of patients |
| Phased RFA System | Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy | Major procedure related event (stroke) | 0.2 percentage of patients |
Other Pre-specified
Procedural Efficiency - Number of Adjunctive Devices Used
Parameters to measure the efficiency: adjunctive devices used
Time frame: Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phased RFA System | Procedural Efficiency - Number of Adjunctive Devices Used | 209 procedures |
Other Pre-specified
Procedural Efficiency - Number of Catheters Used
Parameters to measure the efficiency: Phased RFA consumables used
Time frame: Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phased RFA System | Procedural Efficiency - Number of Catheters Used | 2.2 catheters | Standard Deviation 1.3 |
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
Time frame: Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phased RFA System | Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time | General Procedure Time | 107.0 Minutes | Standard Deviation 39.5 |
| Phased RFA System | Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time | Duration of PVAC ablation | 58.0 Minutes | Standard Deviation 28.8 |
| Phased RFA System | Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time | Time from delivery to cathlab to 3D Mapping | 171.1 Minutes | Standard Deviation 66.1 |
| Phased RFA System | Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time | Cathlab Occupancy Time | 154.7 Minutes | Standard Deviation 49.3 |
| Phased RFA System | Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time | Total Fluoroscopy Time | 25.0 Minutes | Standard Deviation 15.5 |
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).
Time frame: Patient will be followed for minimum 12 months, maximum 14 months, 12 month reported
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phased RFA System | Quality of Life Dynamic - AFEQT Score at 12 Months | AFEQT Score at Baseline | 56.6 score on a scale | Standard Deviation 20.3 |
| Phased RFA System | Quality of Life Dynamic - AFEQT Score at 12 Months | AFEQT Score at 12 Months Follow-Up (site visit) | 82.6 score on a scale | Standard Deviation 18 |
| Phased RFA System | Quality of Life Dynamic - AFEQT Score at 12 Months | AFEQT Score at 12 Months Follow-Up (phone call) | 85.4 score on a scale | Standard Deviation 18.6 |
| Phased RFA System | Quality of Life Dynamic - AFEQT Score at 12 Months | Changes in QoL Score Baseline to 12 M FU (visit) | 24.5 score on a scale | Standard Deviation 23 |
| Phased RFA System | Quality of Life Dynamic - AFEQT Score at 12 Months | Changes in QoL Score Baseline to 12 M FU (phone) | 29.1 score on a scale | Standard Deviation 24.9 |
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
Time frame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Population: Patients with persistent AF only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phased RFA System | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions | 3.0 cardioversions | Standard Deviation 1 |
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
Time frame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Population: Persistent AF patients only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phased RFA System | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure | Phased RFA catheters used | 100 percentage of patient procedures |
| Phased RFA System | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure | MAAC catheters used | 5.4 percentage of patient procedures |
| Phased RFA System | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure | MASC catheters used | 4.7 percentage of patient procedures |
| Phased RFA System | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure | Other catheters | 11.5 percentage of patient procedures |
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
Time frame: Patient will be followed in the Catheterization Laboratory (hereafter CathLab)/operating room during approximately 2 hours of Phased RFA procedure duration
Population: Patients with persistent AF only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phased RFA System | 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 | 71.0 percentage of persistent AF patients |
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
Time frame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Population: Patients with persistent AF only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phased RFA System | Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used | 2.1 catheter | Standard Deviation 1.1 |