Medtronic Terminate AF Study

Medtronic

Status: Enrolling

Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Treatments: Procedure: Surgical Ablation; Device: Cardioblate and Cryoflex hand held devices

Study type: Interventional

Funder types: Industry

Identifiers

NCT03546374

MDT17066ECT001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

160 participants in 1 patient group

Primary Cohort

Experimental group

Description:

Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery

Treatment:

Device: Cardioblate and Cryoflex hand held devices

Procedure: Surgical Ablation