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The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Patients enrolled and treated with the DiamondTemp™ Ablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DiamondTemp™ Ablation System | Device | A cardiac ablation will be performed using the DiamondTemp™ Ablation System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Recurrence at 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. | 12 Months |
| Freedom from Device / Procedure Related Adverse Events | Estimate serious device and serious procedure-related adverse events 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 (or minimum age as required by local regulations) who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunshine Coast University Hospital | Birtinya | QLD 4757 | Australia | |||
| Fiona Stanley Hospital |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Murdoch |
| 6150 |
| Australia |
| Universitair Ziekenhuis Brussel | Jette | 1090 | Belgium |
| CHRU de Tours - Hôpital Trousseau | Chambray-lès-Tours | 37170 | France |
| Capio - Clinique du Tonkin | Villeurbanne | 69300 | France |
| Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum | Bad Oeynhausen | 32545 | Germany |
| Universitäres Herzzentrum | Hamburg | 20246 | Germany |
| Saint Vincenz Krankenhaus Paderborn | Paderborn | 33098 | Germany |
| Humanitas Mater Domini | Castellanza | 21053 | Italy |
| Ospedale di Conegliano - S. Maria dei Battuti | Conegliano | 31015 | Italy |
| Ospedale dell'Angelo | Venezia | 21053 | Italy |
| Catharina Ziekenhuis | Eindhoven | 5623 | Netherlands |
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | 3435 CM | Netherlands |
| John Paul II Upper Silesian Medical Centre | Katowice | 40-752 | Poland |
| Hospital de Santa Marta | Lisbon | 1169-024 | Portugal |
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| Hospital de la Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Inselspital - Universitätsspital Bern | Bern | 3010 | Switzerland |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
| University Hospitals Coventry & Warwickshire | Coventry | CV2 2DX | United Kingdom |