DIAMOND AF Post-Approval Study

Medtronic Cardiac Ablation Solutions84 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

DiamondTemp™ Ablation SystemDEVICE

Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. A diagnosis of recurrent symptomatic paroxysmal AF 2. Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol) 3. Patient is ≥ 18 years of age 4. Planned procedure for the treatment of AF using commercially available DiamondTemp™ Ablation System 5. Patient is willing and able to provide written informed consent 6. Patient is willing and able to comply with study requirements Exclusion Criteria: 1. Prior persistent AF (continuous AF that is sustained \>7 days) 2. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed. 3. 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 4. Patients with contraindications to a Holter monitor 5. Unwilling or unable to comply fully with study procedures and follow-up

Locations (5)

Florida Electrophysiology LLC

Winter Park, Florida, United States

Centre Hospitalier de Pau - Hôpital François Mitterrand

Pau, France

Reunion University Hospital - Saint Pierre

Saint-Pierre, France

Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

Ancona, Italy

Outcomes

Primary Outcomes

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.

Time frame: 36 month

Freedom from Primary Safety Events

Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.

Time frame: 12 months

Data from ClinicalTrials.gov

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