A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Medtronic Cardiac Ablation Solutions
- Enrollment
- 376
- Locations
- 28
- Primary Endpoint
- Primary Safety Events
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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) 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.
- •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
Outcomes
Primary Outcomes
Primary Safety Events
Time Frame: Ablation through 6 months
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
Primary Effectiveness
Time Frame: 12 months
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).
Secondary Outcomes
- Freedom From a Composite of Serious Adverse Events (SAEs)(Within 30-days post-index ablation)
- Freedom From Documented AF/AFL/AT Episodes(Within 3 months)
- Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy.(Within 3 months)
- Acute Procedural Success(Day of index ablation procedure)
- Single Procedure Success With Freedom From AF/AT/AFL(12 months after the index ablation procedure)
- Single Procedure Success With Freedom From All Primary Effectiveness Failures(12 months)
- AFEQT Quality of Life, Baseline(Day of index ablation procedure)
- AFEQT Quality of Life, 6-month Follow-up(6 months after index ablation procedure)
- AFEQT Quality of Life, 12-month Follow up(12 months after index ablation procedure)
- Change in AFEQT Quality of Life From Baseline to 12-month(Index ablation procedure through 12 months)
- National Institutes of Health Stroke Scale, Pre-discharge(Day of index ablation procedure)
- National Institutes of Health Stroke Scale, One- Month Follow up(One month after index ablation procedure)
- National Institutes of Health Stroke Scale, 12-month Follow-up(12 months after the index ablation procedure)