DiamondTemp Global Registry

Medtronic Cardiac Ablation Solutions

Status

Enrolling

Conditions

Arrhythmia

Treatments

Device: DiamondTemp™ Ablation System

Study type

Observational

Funder types

Industry

Identifiers

NCT04735016

MDT20059

Details and patient eligibility

About

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

Full description

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the commercially available DiamondTemp™ Family of Cardiac Ablation Catheters (hereafter referred to as the DiamondTemp™ Ablation System) and followed according to the standard of care at each respective institution. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is ≥ 18 years of age or minimum age as required by local regulations
Planned procedure using commercially available DiamondTemp™ Ablation System
Willing 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