DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation (Diamond-AFII)

Medtronic

Status: Completed

Conditions: Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Device: Radiofrequency Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03643224

TP01071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 376 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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376 participants in 1 patient group

Experimental

Experimental group

Description:

Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter

Treatment:

Device: Radiofrequency Ablation