Atrial FibrillationNCT02433613
Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 41 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,071 participants
- Where
- 41 sitesin 14 countries
- Study dates
- Mar 2015to May 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible are all patients with paroxysmal, persistent and long-standing persistent AF who fulfill all inclusion criteria.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
41 sites in 14 countries.
41 sites in 14 countries
Germany6 sites
St. Johannes Hospital
Dortmund
Evangelisches Krankenhaus
Düsseldorf
Helios Klinikum Erfurt
Erfurt
Herz- und Gefäßzentrum Oberallgäu-Kempten
Kempten
Universitätsklinikum Münster
Münster
St. Vincenz-Krankenhaus Paderborn
Paderborn
South Korea6 sites
Sejong General Hospital
Bucheon-si
Keimyung University Dongsan Hospital
Daegu
Yeungnam University Hospital
Daegu
Chonnam National University Hospital
Gwangju
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Italy5 sites
A.O. Papa Giovanni XXIII
Bergamo
Az. Osped. Pugliese Ciaccio
Catanzaro
Ospedale Mater Salutis
Legnago
A.O. Osped. S.Gerardo
Monza
A.O. San Camillo Forlanini
Rome
France4 sites
CHU Angers
Angers
CHU de Bordeaux
Bordeaux
CMC Parly 2
Le Chesnay, 78150
Centre Cardiologique du Nord
Saint-Denis
Israel4 sites
The Barzilai Medical Center Ashkleon
Ashkelon
Soroka University Medical Center
Beersheba
Hadassah Medical Center
Jerusalem
Kaplan Medical Center
Rehovot
Poland4 sites
Samodzielny Publiczny Szpital Kliniczny Nr 4
Lublin
Samodzielny Publiczny Szpital Kliniczny Nr 2
Szczecin
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw
4 Wojskowy Szpital Kliniczny
Wroclaw
Spain3 sites
Hospital Donostia
Donostia / San Sebastian
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Netherlands2 sites
Medisch Centrum Leeuwarden B.V.
Leeuwarden
St. Antonius Ziekenhuis
Nieuwegein
Portugal1 site
Centro Hospitalar Lisboa Notre - Hospital de Santa Maria E.P.E.
Lisbon
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Pulmonary Vein Isolation, Phased Radiofrequency Ablation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Secondary outcomes (1)
Estimate Phased RFA Mid-term Safety
Estimate major procedure/system related complications of Phased RFA
Measured: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMar 2015
- Primary completion20 Nov 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,071 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IHF GmbH - Institut für Herzinfarktforschung
- Responsible party
- Sponsor
- Investigators
- Lucas Boersma, MD, Ph.D, Principal investigator, St. AntoniousMeleze Hocini, MD, Principal investigator, Hôpital Cardiologique du Haut-Lévêque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433613
- Sponsor's protocol ID
- GOLD AF
- Status last verified
- Feb 2025
- First submitted
- 17 Mar 2015
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
- ClinicalTrials.gov ID
- NCT02433613
- Acronym / sponsor ID
- GOLD AF
- Conditions
- Atrial Fibrillation
- Keywords
- Pulmonary Vein Isolation, Phased Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,071 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- IHF GmbH - Institut für Herzinfarktforschung
- Study start
- Mar 2015 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible are all patients with paroxysmal, persistent and long-standing persistent AF who fulfill all inclusion criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate
Time frame: 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.
1 secondary outcome
Estimate Phased RFA Mid-term Safety
Time frame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Boersma, MD, Ph.D principal investigator
St. Antonious
Meleze Hocini, MD principal investigator
Hôpital Cardiologique du Haut-Lévêque
41 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 41 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Germany, South Korea, Italy, France, Israel and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate (time frame: Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.