Atrial Fibrillation
Conditions
Brief summary
The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.
Detailed description
* 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.
Interventions
DEVICEDiamondTemp Cardiac Ablation System
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
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from a composite of serious adverse events (SAE) | 30 days | Freedom from a composite of serious adverse events (SAE) |
| Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes | 12 months | Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from a composite SAE | 7 days | Freedom from a composite SAE |
| Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes | 12 months | Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes |
| Rate of single procedure success | 12 months | Rate of single procedure success |
Countries
Czechia, France
Outcome results
None listed