Arrhythmia
Conditions
Brief 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.
Interventions
A cardiac ablation will be performed using the DiamondTemp™ Ablation System.
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Recurrence at 12 Months | 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. |
| Freedom from Device / Procedure Related Adverse Events | 12 Months | Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months. |
Countries
Australia, Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Slovenia, Spain, Switzerland, United Kingdom
Outcome results
None listed