DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Medtronic Cardiac Ablation Solutions376 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

376

Conditions

Persistent Atrial Fibrillation Atrial Fibrillation

Interventions

Radiofrequency AblationDEVICE

A procedure will be performed using a radiofrequency ablation catheter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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) 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. 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

Locations (28)

Outcomes

Primary Outcomes

Primary Safety Events

Participant count of a composite of safety events including: serious adverse events (SAEs), procedure and/or device-related significant pericardial effusion, severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula

Time frame: Ablation through 6 months

Primary Effectiveness

The primary effectiveness endpoint is defined as freedom from documented AF, Atrial Flutter, (AFL) and Atrial Tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).

Time frame: 12 months

Secondary Outcomes

Freedom From a Composite of Serious Adverse Events (SAEs)

Freedom from a composite of SAEs occurring within 30-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device.

Time frame: Within 30-days post-index ablation

Freedom From Documented AF/AFL/AT Episodes

Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period lasting ≥ 30 seconds in duration by ECG monitoring.

Time frame: Within 3 months

Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy.

Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy.

Time frame: Within 3 months

Acute Procedural Success

Participant count of acute procedural success, defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 18 more locations

Time frame: Day of index ablation procedure

Single Procedure Success With Freedom From AF/AT/AFL

Participant count of single procedure success defined as the rate of subjects treated with one single ablation procedure for the entire enrollment period and with freedom from documented symptomatic AF, AT and AFL\* at 12 months.

Time frame: 12 months after the index ablation procedure

Single Procedure Success With Freedom From All Primary Effectiveness Failures

Participant count of single procedure success with freedom from all primary effectiveness failure criteria.

Time frame: 12 months

AFEQT Quality of Life, Baseline

QOL using the AFEQT Questionnaire, baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.

Time frame: Day of index ablation procedure

AFEQT Quality of Life, 6-month Follow-up

QOL using the AFEQT Questionnaire, 6 month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.

Time frame: 6 months after index ablation procedure

AFEQT Quality of Life, 12-month Follow up

QOL using the AFEQT Questionnaire, 12-month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.

Time frame: 12 months after index ablation procedure

Change in AFEQT Quality of Life From Baseline to 12-month

Changes in QOL using the AFEQT Questionnaire between 12-month and baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.

Time frame: Index ablation procedure through 12 months

National Institutes of Health Stroke Scale, Pre-discharge

Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.