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OpenTrials
Completed

NCT Number: NCT02433613

Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Estimate Phased RFA Mid-term Safety

    Time frame: 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 outcomes

  1. Acute Procedural Success Rate

    Time frame: 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

  2. Procedural Efficiency - Procedure Duration, Laboratory Occupancy Duration and 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

    Parameters to measure the efficiency: procedure duration, laboratory occupancy duration, fluoroscopy time

  3. Peri-procedural Anticoagulation Therapy - Activated Clotting Time

    Time frame: 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

  4. Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Phased RFA Catheters Used

    Time frame: 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

  5. Quality of Life Dynamic - AFEQT Score at 12 Months

    Time frame: 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).

  6. Procedural Efficiency - Number of Catheters Used

    Time frame: 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

  7. Procedural Efficiency - Number of 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

    Parameters to measure the efficiency: adjunctive devices used

  8. Peri-procedural Anticoagulation Therapy - International Normalized Ratio (INR)

    Time frame: 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.

  9. Peri-procedural Anticoagulation Therapy - Percent of Participants With Previous and Peri-Procedural Anticoagulation Therapy

    Time frame: 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

  10. Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Number Total Cardioversions

    Time frame: 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

  11. 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

    Time frame: 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

  12. Single Catheter PVAC (Pulmonary Vein Ablation Catheter) GOLD Utilization in Persistent AF Ablation - Percentage of Catheters Used Per Participant Procedure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Ablation Solutions

Industry

Collaborators

  • IHF GmbH - Institut für Herzinfarktforschung

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 5, 2015
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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