Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

Detailed Description
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The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation. In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.

Official Title
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A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: DiamondTemp Cardiac Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suitable candidate for intra-cardiac mapping and ablation for arrhythmias History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days (12) months prior to enrollment At least 1 episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment Refractory to at least one Class I-IV anti-arrhythmic drug (AAD) Eighteen (18) years of age or above Exclusion Criteria: Previous left atrial ablation procedure Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement Known severe cerebrovascular disease or history of cerebrovascular event (< 1 month) Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. Active gastrointestinal bleeding Active infection or fever (>100.5 F/38 ◦C) Sepsis Cardiac surgery within the past two months. Short life expectancy (<1 yr.) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease Significant anemia (hemoglobin < 8.0 mg/dL) Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg within the last 30 days) Documented anaphylaxis during previous exposure to angiographic contrast media Uncontrolled congestive heart failure (NYHA1 Class III or IV) Unstable angina or acute myocardial infarction within the past three months Bleeding, clotting disorders, or known thrombosis Severe Peripheral vascular disease Uncontrolled diabetes Heart valve replacement Mitral clip (E-valve) Women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study Active participation in another investigational protocol currently or the last 30 days Unable or unwilling to take anti-coagulants Unwilling or unable to comply with any protocol or follow up requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DiamondTemp Cardiac Ablation System<br>Cardiac ablation procedure | Device: DiamondTemp Cardiac Ablation System<br>* The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of: DiamondTemp Ablation Catheter o Unidirectional and Bidirectional models DiamondTemp Catheter-to RFG Cable DiamondTemp GenConnect Cable DiamondTemp FASTR Generator with Footswitch DiamondTemp Irrigation Pump DiamondTemp Irrigation Tubing Set<br>* Other names: Cardiac ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 12 months | 
| Rate of single procedure success | Rate of single procedure success | 12 months |