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

Medtronic Cardiac Ablation Solutions

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02433613

GOLD AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,071 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design