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Safety and Efficacy of Cryothermia to Treat Longstanding Persistent Atrial Fibrillation (AF)

This study has been completed.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center ) Identifier:
First received: March 16, 2012
Last updated: January 31, 2017
Last verified: January 2017
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support evidence that the Cardioblate System is safe and effective to treat AF.

Condition Intervention
Longstanding Persistent Atrial Fibrillation
Device: Medtronic Cardioblate CryoFlex

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Cryo-AF Clinical Study

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • The primary efficacy endpoint is the percentage of patients diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings at 12 months. [ Time Frame: 12 months ]
  • The primary safety endpoint is the rate of device and procedure related acute major adverse events within 30 days post-procedure or prior to hospital discharge. [ Time Frame: 30 days ]

Enrollment: 17
Study Start Date: September 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cox Cryo Maze III procedure Device: Medtronic Cardioblate CryoFlex
Patients will have their scheduled surgery plus, during the same procedure, their AF will be treated with the Cardioblate CryoFlex Surgical Ablation System to perform the Cox Cryo Maze III procedure. In addition they will receive an implantable monitor.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have a documented history of longstanding persistent AF as defined by the HRS/EHRA/ECAS Guidelines
  • Patients should have a concomitant indication (other than AF) for open-heart surgery for mitral valve repair or replacement (bioprosthesis)
  • Patients should be older than or equal to 18 years of age

Exclusion Criteria:

  • Atrioventricular reentrant tachycardia (AVRT)
  • NYHA Class = IV
  • Left ejection fraction of ≤ 30%
  • Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery
  • Previous atrial fibrillation ablation, AV-nodal ablation, or surgical Maze procedure
  • Contraindication for anticoagulation therapy
  • Left atrial diameter > 7.0 cm
  • Preoperative need for intra-aortic balloon pump or intravenous inotropes
  • Renal failure requiring dialysis or hepatic failure
  • Life expectancy of less than one year
  • Pregnancy or desire to be pregnant within 12 months of the study treatment
  • Current diagnosis of active systemic infection
  • Documented MI 6 weeks prior to study enrollment
  Contacts and Locations
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Please refer to this study by its identifier: NCT01558635

Herzzentrum Leipzig GmbH
Leipzig, Germany
Sheba Medical Center
Tel-Hashomer, Israel
San Raffaele Hospital
Milan, Italy, 20149
Hospital Clinic de Barcelona
Barcelona, Spain
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

Responsible Party: Medtronic Bakken Research Center Identifier: NCT01558635     History of Changes
Other Study ID Numbers: MDT-CRYO-001
Study First Received: March 16, 2012
Last Updated: January 31, 2017

Keywords provided by Medtronic Cardiovascular:
Atrial Fibrillation
Surgical ablation
Maze procedure

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 25, 2017