Affera Global Registry

Atrial Fibrillation Clinical Trial

Official title:

The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06026345
• Other study ID #: Affera Global Registry
• Status: Not yet recruiting
• Start date: December 6, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: October 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Ryan Radtke
• Phone: +17129419372
• Email: ryan.s.radtke[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: July 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Affera Platform
A cardiac ablation will be performed using the Affera Platform

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective #1 (Efficacy)	Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.	12 Month Post Proceedure
Secondary	Primary Objective #2 (Safety)	Estimate serious device and serious procedure-related adverse events for the Affera Platform.	90 Days Post Proceedure