An observational study in Paroxysmal Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions. Terminated at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Medtronic Cardiac Ablation Solutions · Observational
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial
The DIAMOND AF PAS is a prospective, global, multi-center, non-randomized, single-arm observational trial. This post approval study is a condition of the Pre-Market Approval order (P200028/S002) by the U.S. Food and Drug Administration." The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Ablation System. To assess clinical performance and safety of the DiamondTemp™ Ablation System, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. Additionally, study objectives will characterize the ablation procedure, change in QoL through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (AE) through 36 months.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 84 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Medtronic Cardiac Ablation Solutions is the lead sponsor of 37 studies on the registry; 10 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects ≥ 18 years of age who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.
Exclusion Criteria:
Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System.
Time frame: 36 month
Freedom from Primary Safety Events
Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.
Time frame: 12 months
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Ablation Solutions