Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law. 2. 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) a 24-hour Holter within 90 days of the ablation procedure showing continuous AF. 3. Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug. 4. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia. 5. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment. 6. Subject is willing and able to provide written consent.

Exclusion Criteria

At time of enrollment and/or prior to procedure: 1. Continuous AF >12 months (long-standing persistent AF) 2. Paroxysmal AF with longest episode <7 days 3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause 4. Rheumatic heart disease 5. Severe mitral regurgitation 6. Hypertrophic cardiomyopathy 7. LA diameter >5.5 cm 8. Left ventricular ejection fraction (LVEF) <40% 9. Currently NYHA Class III or IV or exhibits uncontrolled heart failure 10. Body Mass Index (BMI) >42 kg/m2. 11. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment 12. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation 13. Coagulopathy, bleeding diathesis or suspected procoagulant state 14. Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) within a week prior to the ablation procedure 15. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition 16. 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. 17. 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. 18. Positive pregnancy test results for female subjects of childbearing potential or breast feeding. 19. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes. 20. 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. 21. 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: 22. Documented LA thrombus upon imaging 23. Creatinine >2.5mg/dl or creatinine clearance <30mL/min Within 3 months of enrollment: 24. Significant gastrointestinal (GI) bleed 25. Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention Within 6 months of enrollment: 26. Coronary artery bypass graft (CABG) procedure 27. Implant procedure performed for ICD, CRT leads or pacemaker 28. Documented stroke, CVA, TIA or suspected neurological event

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental
Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter
  • Device: Radiofrequency Ablation
    A procedure will be performed using a radiofrequency ablation catheter.

More Details

Status
Active, not recruiting
Sponsor
Medtronic Cardiac Rhythm and Heart Failure

Study Contact

Detailed Description

The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) trial being performed at multiple centers in the United States, Canada and Europe to evaluate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of patients with persistent atrial fibrillation.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.