DiamondTemp™ Ablation System
DeviceA cardiac ablation will be performed using the DiamondTemp™ Ablation System.
NCT Number: NCT04735016
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Sunshine Coast University Hospital, Birtinya, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A cardiac ablation will be performed using the DiamondTemp™ Ablation System.
Time frame: 12 Months
Estimate the 12-month freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the DiamondTemp™ Ablation System.
Time frame: 12 Months
Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months.
Medtronic Cardiac Ablation Solutions
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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