DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Completed · Not applicable

Conditions studied: Persistent Atrial Fibrillation, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03643224

Run by

Medtronic Cardiac Ablation Solutions

People needed

376

Starts

2018-09-19

Expected to finish

2024-10-31

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
• 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.
• Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.
• Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
• Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
• Subject is willing and able to provide written consent.

You may not qualify if…

• At time of enrollment and/or prior to procedure:
• Continuous AF >12 months (long-standing persistent AF)
• Paroxysmal AF with longest episode <7 days
• AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
• Rheumatic heart disease
• Severe mitral regurgitation
• Hypertrophic cardiomyopathy
• LA diameter >5.5 cm
• Left ventricular ejection fraction (LVEF) <40%
• Currently NYHA Class III or IV or exhibits uncontrolled heart failure
• Body Mass Index (BMI) >42 kg/m2.
• LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment
• Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation
• Coagulopathy, bleeding diathesis or suspected procoagulant state
• Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) within a week prior to the ablation procedure
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
• Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
• Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
• Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
• Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
• Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
• Life expectancy <12 months based on medical history or the medical judgement of the investigator.
• Within 1 month of enrollment or just prior to procedure:
• Documented LA thrombus upon imaging
• Creatinine >2.5mg/dl or creatinine clearance <30mL/min

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• University Of Alabama — Birmingham, Alabama, United States
• Keck School Of Medicine — Los Angeles, California, United States
• Advent Health, Florida Hospital Orlando — Orlando, Florida, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Montefiore Medical Center — New York, New York, United States
• Trident Medical Center — Charleston, South Carolina, United States
• Medical University Of South Carolina — Charleston, South Carolina, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Southlake Regional Health Center — Newmarket, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) — Québec, Quebec, Canada
• Institut Klinicke a Experimentalni Mediciny (IKEM) — Prague, Czechia, Czechia
• Na Homolce — Prague, Prague, Czechia
• St Ann's University Hospital — Brno, Czechia
• Clinique du Tonkin — Villeurbanne, Lyon, France
• CHRU Nancy — Nancy, France
• Clinique Saint Pierre — Perpignan, France
• Clinique Pasteur — Toulouse, France

Full record on ClinicalTrials.gov

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