NCT04735016

DiamondTemp Global Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Arrhythmia

Interventions

Type	Name	Description
DEVICE	DiamondTemp™ Ablation System	A cardiac ablation will be performed using the DiamondTemp™ Ablation System.

Timeline

• Start date: 2021-04-22
• Primary completion: 2031-03-01
• Completion: 2031-03-01
• First posted: 2021-02-02
• Last updated: 2026-02-03

Locations

21 sites across 12 countries: Australia, Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Slovenia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study