A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Paroxysmal Atrial Fibrillation
- Sponsor
- Medtronic Cardiac Ablation Solutions
- Enrollment
- 482
- Locations
- 23
- Primary Endpoint
- Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)
Time Frame: Within 30-days or 6-months after index ablation procedure
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
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).
Time Frame: 3-12M (3-12 months) after index ablation procedure
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
Secondary Outcomes
- Total Fluid Infused Through the Ablation Catheter (mL)(Index ablation procedure)
- Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)(Index ablation procedure)
- Rate of Acute Procedural Success(Index ablation procedure)
- Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months.(Index ablation procedure through 12-months after index ablation procedure)
- Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs)(Index ablation procedure)
- Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)(Index ablation procedure)
- Total Fluoroscopy Time (Minutes)(Index ablation procedure)
- Mean Cumulative RF Time Per Procedure (Minutes)(Index ablation procedure)
- Freedom From a Composite of SAE Occurring Within 7-days(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).(3-12 months after index ablation procedure)
- Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria.(Index ablation procedure through 12-months after index ablation procedure)
- Total Procedure Time (Minutes)(Index ablation procedure)
- Total Treatment Device Time (Minutes)(Index ablation procedure)
- Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS)(Baseline, pre-discharge after index ablation and 12-months after index ablation procedure)
- Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period(3-12 months after index ablation procedure)
- Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire(Baseline, 6-months after index ablation and 12-months after index ablation)
- Total Number of RF Ablations Per Procedure(Index ablation procedure)