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Sponsor and FDA agreed on early termination. Results will be posted by the FDA on the FDA Post-Approval Studies (PAS) Database- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma\_pas.cfm?t\_id=697443\&c\_id=6450
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DiamondTemp™ Ablation System | Device | Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 month |
| Freedom from Primary Safety Events | Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Tarakji, MD | Medtronic CAS Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Electrophysiology LLC | Winter Park | Florida | 32792 | United States | ||
| Centre Hospitalier de Pau - Hôpital François Mitterrand |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Pau |
| 64046 |
| France |
| Reunion University Hospital - Saint Pierre | Saint-Pierre | 97448 | France |
| Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona | Ancona | 60030 | Italy |
| Humanitas Mater Domini | Varese | 21053 | Italy |
| D013568 |
| Pathological Conditions, Signs and Symptoms |