DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation, Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) a 24-hour Holter within 90 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. Exclusion Criteria: 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 Within 3 months of enrollment: Significant gastrointestinal (GI) bleed Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention Within 6 months of enrollment: Coronary artery bypass graft (CABG) procedure Implant procedure performed for ICD, CRT leads or pacemaker Documented stroke, CVA, TIA or suspected neurological event

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter | Device: Radiofrequency Ablation<br>* A procedure will be performed using a radiofrequency ablation catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device or procedure related Serious Adverse Events measured at 7 days in all subjects | Freedom from a composite of pre-specified Serious Adverse Events | 7 days after the index ablation procedure | 
| Incidence of device or procedure related clinically significant tamponade/perforation measured at 30 days in all subjects. | Freedom from clinically significant tamponade/perforation occurring through 30 days. | 30 days after the index ablation procedure | 
| Incidence of symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months in all subjects. | Freedom from symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months | 6 months after the index ablation procedure | 
| Incidence of documented symptomatic atrial fibrillation, atrial flutter and atrial tachycardia episodes for all subjects. | Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter* (AFL) and atrial tachycardia (AT) episodes following the blanking period through the end of the effectiveness evaluation period. | Between 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device or procedure related Serious Adverse Events measured at 30 days in all subjects. | Freedom from a composite of pre-specified Serious Adverse Events | 30 days after the index ablation procedure | 
| Incidence of documented symptomatic atrial fibrillation, atrial flutter and atrial tachycardia episodes in the absence of class I and II anti-arrhythmic drug therapy for all subjects. | Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy. | Between 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). | 
| Incidence of asymptomatic pericardial effusion of 1cm or more in size | Rate of asymptomatic pericardial effusion of 1cm or more in size as documented by echocardiography up to 30 days following the index procedure | 30 days after the index ablation procedure | 
| Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation period lasting ≥30 seconds in duration by ECG or ECG monitoring system | Freedom from documented asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation period lasting ≥30 seconds in duration by ECG or ECG monitoring system | Between 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). | 
| Rate of acute procedural success | Rate 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 | Day of index ablation procedure | 
| Rate of single procedure success | Rate 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. | 12 months after the index ablation procedure | 
| Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period | Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure. | Day of index ablation procedure | 
| Accumulated changes in Quality of Life (QOL) using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire | Accumulated changes in QOL using the AFEQT Questionnaire from baseline through 6 and 12 months following ablation procedure. Section 1 measures occurrence of atrial fibrillation by asking the subject if they are in atrial fibrillation. If they answer No, it asks for the last time they had atrial fibrillation ranging from the subject were never aware of having atrial fibrillation (minimum) to more than 1 year ago (maximum). Section 2 measures how atrial fibrillation affects the subject's quality of life by asking a series of 20 questions that the subject rates on a scale of 1 to 7, how much was the subject bothered by their atrial fibrillation, one being Not at all bothered and 7 being Extremely bothered. | Between 6 months and 12 months after the index ablation procedure | 
| 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. 1a. Level of Consciousness (LOC) 0 - 3 1b. LOC Questions 0 - 2 1c. LOC Commands 0 - 2 2. Best Gaze 0 - 2 3. Visual 0 - 3 4. Facial Palsy 0 - 3 5. Motor Arm. 0 - 4 or UN = Amputation or joint fusion. Scored for both left and right arms. 6. Motor Leg. 0 - 4 or UN = Amputation or joint fusion. Scored for both left and right legs. 7. Limb Ataxia. 0 - 2 or UN = Amputation or joint fusion 8. Sensory. 0 - 2 9. Best Language. 0 - 3 10. Dysarthria. 0 - 2 or UN = Intubated or other physical barrier. 11. Extinction and Inattention. 0 - 2 | Between baseline and 12 months after the index ablation procedure | 
| Total procedure time (minutes) | Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed. | Immediately after the index ablation procedure | 
| Total time to achieve initial PVI (minutes) | Time to achieve initial PVI at index procedure (minutes), defined as time of delivery of first RF ablation with the investigational catheter until confirmation of PVI via entrance block following a 20-minute waiting period. | Day of index ablation procedure | 
| Ability to perform first-pass PV antral isolation | Ability to perform first-pass PV antral isolation | Day of index ablation procedure | 
| Total treatment device time (minutes) | Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter. | Day of index ablation procedure | 
| Mean cumulative RF Time (minutes). | Mean cumulative RF Time (minutes). | Day of index ablation procedure | 
| Mean duration of RF ablations (seconds) | Mean duration of RF ablations (seconds) | Day of index ablation procedure | 
| Total fluid infused through the investigational catheter (mL) | Total fluid infused through the investigational catheter (mL) | Day of index ablation procedure | 
| Total fluoroscopy time (minutes) | Total fluoroscopy time (minutes) | Day of index ablation procedure | 
| Incidence of re-hospitalizations due to atrial fibrillation recurrence. | Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period. | Between 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). | 
| Incidence of asymptomatic AF, AFL* or AT episodes through the effectiveness evaluation | Freedom from documented asymptomatic AF, AFL* or AT episodes during effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy | Between 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ablation, electrophysiology, atrial fibrillation, catheter, persistent