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Purpose

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 AF.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - NYHA Class = IV - Left Ventricular Ejection Fraction ≤ 30% - Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery - Previous AF ablation, 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Primary Cohort 		Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery
  • Procedure: Surgical Ablation
    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.
  • Device: Cardioblate and Cryoflex hand held devices
    The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Serguei Melnitchouk, MD
smelnitchouk@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Medtronic Cardiac Surgery

Study Contact

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

Detailed Description

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.