DIAMOND AF Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial

Detailed Description
-----------------
The DIAMOND AF PAS is a prospective, global, multi-center, non-randomized, single-arm observational trial. This post approval study is a condition of the Pre-Market Approval order (P200028/S002) by the U.S. Food and Drug Administration. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Ablation System. To assess clinical performance and safety of the DiamondTemp™ Ablation System, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. Additionally, study objectives will characterize the ablation procedure, change in QoL through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (AE) through 36 months.

Official Title
-----------------
DIAMOND AF Post-Approval Study

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: DiamondTemp™ Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of recurrent symptomatic paroxysmal AF: a) Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following: i) Physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and ii) At least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol) Patient is ≥ 18 years of age Planned de novo pulmonary vein isolation (PVI) procedure using commercially available DiamondTemp™ Ablation System Patient (or patient's legally authorized representative) is willing and able to provide written informed consent Patient is willing and able to comply with study requirements Exclusion Criteria: Prior persistent AF (continuous AF that is sustained >7 days) Prior left atrial ablation or left atrial surgical procedure Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) Presence of any pulmonary vein stents Known presence of any pre-existing pulmonary vein stenosis Presence of any cardiac valve prosthesis Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) /Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 90 day interval preceding the date the subject signed the Informed Consent Form Unstable angina Contraindication to anticoagulation therapy Active systemic infection Hypertrophic cardiomyopathy Any cerebral ischemic event (strokes or Transient Ischemic Attacks (TIA)) which occurred during the 180 day interval preceding the date the patient signed the Informed Consent Form, or any known unresolved complications from previous stroke/TIA Existing thrombus Pregnancy Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic Patients with contraindications to a Holter monitor Unwilling or unable to comply fully with study procedures and follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DiamondTemp™ Ablation System|Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) | Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System. | 36 month | 
| Freedom from Primary Safety Events | Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months. | 12 months |