Affera Global Registry

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06026345
• Collaborator: (none)
• Enrollment: 540
• Anticipated Duration (Months): 57.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Affera Platform

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 540 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
• Anticipated Study Start Date: Sep 6, 2023
• Anticipated Primary Completion Date: Apr 1, 2028
• Anticipated Study Completion Date: Jul 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Treatment Arm Patients enrolled and treated with the Affera Platform	Device: Affera Platform; A cardiac ablation will be performed using the Affera Platform

Outcome Measures

Primary Outcome Measures

1. Primary Objective #1 (Efficacy) [12 Month Post Proceedure]

   Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.

Secondary Outcome Measures

1. Primary Objective #2 (Safety) [90 Days Post Proceedure]

   Estimate serious device and serious procedure-related adverse events for the Affera Platform.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT06026345
• Other Study ID Numbers: Affera Global Registry
• First Posted: Sep 7, 2023
• Last Update Posted: Sep 7, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Sep 7, 2023