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The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DiamondTemp Cardiac Ablation System | Experimental | Cardiac ablation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DiamondTemp Cardiac Ablation System | Device | The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from a composite of serious adverse events (SAE) | Freedom from a composite of serious adverse events (SAE) | 30 days |
| Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes | Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from a composite SAE | Freedom from a composite SAE | 7 days |
| Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes | Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petr Neuzil, MD, PhD | Na Homolce | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce | Prague | 15000 | Czechia | |||
| Clnique du Tonkin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35581464 | Derived | Neuzil P, Poty H, de Chillou C, Petru J, Getman MK, Liu S, Funasako M, Durand-Dubief A, Combes S, Albenque JP. Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF. J Interv Card Electrophysiol. 2023 Mar;66(2):343-351. doi: 10.1007/s10840-022-01234-9. Epub 2022 May 18. |
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The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.
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|
|
| 12 months |
| Rate of single procedure success | Rate of single procedure success | 12 months |
| Lyon |
| France |
| CHRU de Nancy | Nancy | France |
| Clinique Pasteur | Toulouse | France |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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