Medtronic Terminate AF Study

Medtronic Cardiac Surgery160 enrolled

Overview

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).

This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the United States (US). The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months. The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation

Interventions

Surgical AblationPROCEDURE

In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.

Cardioblate and Cryoflex hand held devicesDEVICE

The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of non-paroxysmal AF (persistent or longstanding persistent) * Concomitant indication for non-emergent open-heart surgery, eg, 1. Coronary artery bypass grafting 2. Valve repair or replacement * Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC) Exclusion Criteria: * Wolff-Parkinson-White syndrome * New York Heart Association (NYHA) Class = IV * Left Ventricular Ejection Fraction ≤ 30% * Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery * Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure * Contraindication for anticoagulation therapy * Left atrial diameter \> 6.0 cm * Preoperative need for an intra-aortic balloon pump or intravenous inotropes * Renal failure requiring dialysis or hepatic failure * Life expectancy of less than 1 year * Predicted risk of operative mortality \>10% as assessed by STS Risk Calculator * Pregnancy or desire to be pregnant within 12 months of the study treatment * Current diagnosis of active systemic infection * Active endocarditis * Documented MI 30 days prior to study enrollment * Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

Locations (15)

Stanford Hospitals and Clinic

Palo Alto, California, United States

COMPLETED

Adventist Health St. Helena

St. Helena, California, United States

Outcomes

Primary Outcomes

Composite acute major adverse event rate

Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death.

Time frame: 30-days post-procedure or hospital discharge (whichever is longer)

Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)

Freedom from AF/AFL/AT of 30 seconds or greater duration on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy.

Time frame: 6-months post-procedure to 12-months post-procedure

Secondary Outcomes

Composite acute major adverse event rate (Safety)

Composite acute major adverse event rate at 6 months post-procedure (as defined above)

Time frame: 6-months post-procedure

Composite acute major adverse event rate (Safety)

Composite acute major adverse event rate at 12 months post-procedure (as defined above)

Time frame: 12-months post-procedure

Percentage of new permanent pacemaker implantation (Safety)

Percentage of new permanent pacemaker implantation presented by indication

Time frame: 12-months post-procedure

Acute procedural success (Efficacy)

Acute procedural success (pulmonary vein isolation)

Time frame: During index procedure

Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)

Central Contacts

Stephanie Yong

CONTACT

763-526-2032 stephanie.yong@medtronic.com

Jessica Halverson

CONTACT

763-514-9765 Jessica.halverson@medtronic.com

Data from ClinicalTrials.gov

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