Trial Outcomes & Findings for Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry) (NCT NCT02433613)

NCT ID: NCT02433613

Last Updated: 2025-02-13

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1071 participants
• Primary outcome timeframe: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
• Results posted on: 2025-02-13

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	1071
Overall Study COMPLETED	1054
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Phased RFA System n=1054 Participants 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.
Age, Continuous	60.6 years STANDARD_DEVIATION 10.9 • n=1054 Participants
Sex: Female, Male Female	341 Participants n=1054 Participants
Sex: Female, Male Male	713 Participants n=1054 Participants
Region of Enrollment Hungary	37 participants n=1054 Participants
Region of Enrollment United Kingdom	6 participants n=1054 Participants
Region of Enrollment Portugal	57 participants n=1054 Participants
Region of Enrollment Switzerland	33 participants n=1054 Participants
Region of Enrollment Spain	73 participants n=1054 Participants
Region of Enrollment Greece	9 participants n=1054 Participants
Region of Enrollment Netherlands	181 participants n=1054 Participants
Region of Enrollment South Korea	73 participants n=1054 Participants
Region of Enrollment Poland	123 participants n=1054 Participants
Region of Enrollment Italy	182 participants n=1054 Participants
Region of Enrollment Israel	40 participants n=1054 Participants
Region of Enrollment Georgia	2 participants n=1054 Participants
Region of Enrollment France	42 participants n=1054 Participants
Region of Enrollment Germany	213 participants n=1054 Participants
Body-Mass-Index (BMI)	27.8 kg/m2 STANDARD_DEVIATION 4.5 • n=1054 Participants
Atrial Fibrillation (AF) Status Paroxysmal Atrial Fibrillation (PAF)	740 Participants n=1054 Participants
Atrial Fibrillation (AF) Status Persistent Atrial Fibrillation	279 Participants n=1054 Participants
Atrial Fibrillation (AF) Status Longstanding persistent Atrial Fibrillation	35 Participants n=1054 Participants
Symptomatic Atrial Fibrillation	1007 Participants n=1054 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Phased RFA System n=1054 Participants 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.
Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate	185.1 Days Standard Deviation 76.6

SECONDARY outcome

Timeframe: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA

Estimate major procedure/system related complications of Phased RFA

Outcome measures

Measure	Phased RFA System n=1054 Participants 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.
Estimate Phased RFA Mid-term Safety	27 events

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Phased RFA System n=1036 Participants 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.
Acute Procedural Success Rate	94.3 % of procedural success rate

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Phased RFA System n=1048 Participants 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.
Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time General Procedure Time	107.0 Minutes Standard Deviation 39.5
Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time Duration of PVAC ablation	58.0 Minutes Standard Deviation 28.8
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
Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time Cathlab Occupancy Time	154.7 Minutes Standard Deviation 49.3
Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and Fluoroscopy Time Total Fluoroscopy Time	25.0 Minutes Standard Deviation 15.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Phased RFA System n=1054 Participants 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.
Peri-procedural Anticoagulation Therapy - Activated Clotting Time Highest activated clotting time (ACT)	356.9 seconds Standard Deviation 115.7
Peri-procedural Anticoagulation Therapy - Activated Clotting Time Lowest ACT	274.4 seconds Standard Deviation 95.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA

Population: Patients with persistent AF only

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

Outcome measures

Measure	Phased RFA System n=279 Participants 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.
Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used	2.1 catheter Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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".

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).

Outcome measures

Measure	Phased RFA System n=1054 Participants 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.
Quality of Life Dynamic - AFEQT Score at 12 Months AFEQT Score at Baseline	56.6 score on a scale Standard Deviation 20.3
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 18.0
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
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 23.0
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 outcome

Timeframe: 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

Outcome measures

Measure	Phased RFA System n=1054 procedures 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.
Procedural Efficiency - Number of Catheters Used	2.2 catheters Standard Deviation 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Phased RFA System n=1054 procedures 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.
Procedural Efficiency - Number of Adjunctive Devices Used	209 procedures

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Phased RFA System n=1054 Participants 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.
Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR)	1.4 ratio Standard Deviation 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Phased RFA System n=1054 Participants 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.
Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy Major procedure related event (stroke)	0.2 percentage of patients
Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy Oral anticoagulants discontinued before procedure	53.8 percentage of patients
Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy Previously treated with VKA	23.2 percentage of patients
Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy Previously treated with NOACs	63.5 percentage of patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA

Population: Patients with persistent AF only

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

Outcome measures

Measure	Phased RFA System n=279 Participants 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.
Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions	3.0 cardioversions Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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

Outcome measures

Measure	Phased RFA System n=279 Participants 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.
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 outcome

Timeframe: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA

Population: Persistent AF patients only

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

Outcome measures

Measure	Phased RFA System n=279 Participants 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.
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
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
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
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

Adverse Events

Phased RFA System

Serious events: 42 serious events

Other events: 63 other events

Deaths: 4 deaths

Serious adverse events

Measure	Phased RFA System n=1071 participants at risk 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.
General disorders Pneumothorax	0.09% 1/1071 • 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.
General disorders Vascular access complication	1.3% 14/1071 • 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.
General disorders Other diagnosis	1.8% 19/1071 • 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.
General disorders Stroke	0.28% 3/1071 • 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.
General disorders Left Atrial Fibrillation	0.28% 3/1071 • 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.
General disorders Acute Coronary Syndrome	0.09% 1/1071 • 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.
General disorders Phrenic Nerve Damage	0.09% 1/1071 • 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.

Other adverse events

Measure	Phased RFA System n=1071 participants at risk 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.
General disorders Vascular Access Complication	0.65% 7/1071 • 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.
General disorders Other (diagnosis)	4.8% 51/1071 • 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.
General disorders Left Atrial Fibrillation	0.09% 1/1071 • 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.
General disorders Acute Coronary Syndrome	0.09% 1/1071 • 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.
General disorders Pulmonary Vein (PV) Stenosis	0.09% 1/1071 • 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.
General disorders Transient Ischaemic Attack (TIA)	0.09% 1/1071 • 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.
General disorders Bleeding	0.09% 1/1071 • 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.

Additional Information

Dr. Ralf Meyer

Medtronic GmbH

Phone: 01755810431

Email: ralf.meyer@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee Details are described in the project specific Publication Plan.
• Publication restrictions are in place

Restriction type: OTHER