DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

Detailed Description
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The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being performed at multiple centers in the United States, Canada and Europe. The study will evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.

Official Title
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A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation, Atrial Fibrillation

Intervention / Treatment
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* Device: DiamondTemp Ablation catheter
* Device: TactiCath Quartz Ablation catheter


Participation Criteria
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Eligibility Criteria
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STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study: 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 symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF. At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure. Refractory to at least one Class I-IV AAD for treatment of PAF. 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. STUDY EXCLUSION CRITERIA - Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes: At time of enrollment and/or prior to procedure: AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause. LA diameter > 5.5 cm. LVEF < 35%. Currently NYHA Class III or IV or exhibits uncontrolled heart failure. BMI > 40 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°F / 38°C) 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 2 months of enrollment: Regularly (uninterrupted) prescribed amiodarone. Within 3 months of enrollment: Significant GI bleed. MI, unstable angina, cardiac surgery or coronary intervention. Within 6 months of enrollment: CABG procedure. ICD, CRT leads or pacemaker implant procedure. Documented stroke, CVA, TIA or suspected neurological event. Within 12 months of enrollment: An episode of AF lasting >7 days in duration.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DiamondTemp Ablation Catheter<br>Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter | Device: DiamondTemp Ablation catheter<br>* a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter<br>|
| Active Comparator: TactiCath Quartz Ablation Catheter<br>Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter | Device: TactiCath Quartz Ablation catheter<br>* a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) | The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device. The primary safety device- or procedure-related SAE composite will be the combined rate of the following events: Atrioesophageal fistula Bleeding complication Cardiac tamponade / perforation Death Extended hospitalization Myocardial infarction Pericarditis Phrenic nerve paralysis Pulmonary edema Pulmonary vein stenosis Stroke post-ablation Thromboembolism Transient ischemic attack (TIA) post-ablation Vagal nerve injury Vascular access complications | Within 30-days or 6-months after index ablation procedure | 
| Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation). | The primary effectiveness failure is defined by any of the following events: Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period DC cardioversion for AF, AFL or AT during the effectiveness evaluation period A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period More than one (1) repeat ablation procedure during the blanking period | 3-12M (3-12 months) after index ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds) | Mean duration of individual RF ablations (seconds) during the index ablation procedure | Index ablation procedure | 
| Mean Cumulative RF Time Per Procedure (Minutes) | Mean cumulative RF time per procedure (minutes) during the index ablation procedure | Index ablation procedure | 
| Freedom From a Composite of SAE Occurring Within 7-days | Freedom from a composite of SAE occurring within 7-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. The device- or procedure-related SAE composite will be the combined rate of the following events: Atrioesophageal fistula Bleeding complication Cardiac tamponade / perforation Death Extended hospitalization Myocardial infarction Pericarditis Phrenic nerve paralysis Pulmonary edema Pulmonary vein stenosis Stroke post-ablation Thromboembolism Transient ischemic attack (TIA) post-ablation Vagal nerve injury Vascular access complications | Within 7-days after the index ablation procedure | 
| Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). | Freedom from documented 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. | 3-12 months after index ablation procedure | 
| Rate of Acute Procedural Success | Rate of acute procedural success is 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. | Index ablation procedure | 
| Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. | Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from documented AF, AT and AFL at 12 months. | Index ablation procedure through 12-months after index ablation procedure | 
| Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. | Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from ALL primary effectiveness endpoint failure criteria. | Index ablation procedure through 12-months after index ablation procedure | 
| Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) | Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure. | 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 AF QOL Survey (AFEQT Questionnaire) from baseline through 6 and 12 months following ablation procedure. The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire is an atrial fibrillation-specific health-related quality of life Questionnaire. The overall AFEQT score can range from 0 to 100, with 0 corresponding to complete disability and 100 corresponding to no disability. So a higher AFEQT score means a better outcome. | Baseline, 6-months after index ablation and 12-months after index ablation | 
| Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) | Neurological changes measured using the NIH stroke scale between baseline and post-ablation (pre-discharge visit) and at 12 months post-ablation procedure. The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So a higher NIHSS score means a worse outcome. | Baseline, pre-discharge after index ablation and 12-months after index ablation procedure | 
| Total Procedure Time (Minutes) | Total procedure time (minutes) at index procedure is defined as time of first assigned ablation catheter insertion into the vasculature to time of last procedural ablation catheter removed. | Index ablation procedure | 
| Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes) | Time to achieve initial PVI (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation catheter until confirmation of PVI. | Index ablation procedure | 
| Total Treatment Device Time (Minutes) | Total treatment device time (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation treatment catheter to removal of the treatment catheter. | Index ablation procedure | 
| Total Number of RF Ablations Per Procedure | Total number of RF ablations per procedure at index procedure | Index ablation procedure | 
| Total Fluid Infused Through the Ablation Catheter (mL) | Total fluid infused through the assigned ablation catheter (mL) at index procedure | Index ablation procedure | 
| Total Fluoroscopy Time (Minutes) | Total fluoroscopy time (minutes) at index procedure | Index ablation procedure | 
| Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period | Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period | 3-12 months after index 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, paroxysmal