Affera Global Registry
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Cardiac Ablation Solutions
About this trial
The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is ≥ 18 years of age or minimum age as required by local regulations
Planned procedure using the commercially available Affera Platform
Willing and able to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Disqualifiers
Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
Subject with exclusion criteria required by local law
Trial population
Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for an ablation with the Affera Platform may be approached regarding enrollment in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Affera Platform
DeviceA cardiac ablation will be performed using the Affera Platform
Treatment groups
540 Participants
are divided into 1 treatment groupGroup A: Treatment Arm1 intervention
Trial outcomes
Primary outcomes
1
Primary Objective #1 (Efficacy)
Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.
Time frame
12 Month Post ProceedureSecondary outcomes
1
Primary Objective #2 (Safety)
Estimate serious device and serious procedure-related adverse events for the Affera Platform.
Time frame
90 Days Post ProceedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov