DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation (NCT03643224) | Clinical Trial Compass
CompletedNot Applicable
DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
United States376 participantsStarted 2018-09-19
Plain-language summary
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
âś“. Subjects with a history of documented symptomatic, persistent Atrial Fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months AND 2) two electrocardiograms from any form of rhythm monitoring showing continuous AF taken at least 7 days apart OR a 24-hour Holter within 180 days of the ablation procedure showing continuous AF.
âś“. Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.
âś“. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
âś“. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
âś“. Subject is willing and able to provide written consent.
Exclusion criteria
âś•. Continuous AF \>12 months (long-standing persistent AF)
âś•. Paroxysmal AF with longest episode \<7 days
âś•. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause