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Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Subjects With Longstanding Persistent Atrial Fibrillation Requiring Mitral Valve Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT01558635
First received: March 16, 2012
Last updated: April 28, 2017
Last verified: April 2017
  Purpose
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: Maze III procedure with Cardioblate CryoFlex Surgical Ablation System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryo-AF Clinical Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):

Primary Outcome Measures:
  • Efficacy: Percentage of treated subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF at 12 months, and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. [ Time Frame: 12 months ]
  • Safety: the rate of device and procedure related acute major adverse events (MAE) within 30 days post-procedure or prior to hospital discharge, whichever came last. [ 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: Cardioblate CryoFlex Surgical Ablation
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery
Device: Maze III procedure with Cardioblate CryoFlex Surgical Ablation System
During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.

Detailed Description:

Introduction: Among the cardiac arrhythmias, Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population and represents an increasing problem worldwide. Management strategies for AF include combinations of various treatments, including surgery. Cox et al. developed the surgical Maze procedure to restore sinus conduction to the AV node and to restore effective, synchronized bi-atrial contraction. In an effort to address the observed challenges and make this treatment available to more subjects, modifications of the Maze pattern and new lesion patterns have being developed and tested. Devices using new technologies, like cryothermia, were developed in an effort to reduce the time required to make the lesion pattern.The Cardioblate® CryoFlex™ Surgical Ablation System has been successfully used for the surgical ablation of cardiac arrhythmias including atrial fibrillation. The system utilizes cryothermia to create the linear lesions of the surgical Maze-III procedure.

Purpose: To provide clinical evidence showing that the Cox Cryo Maze III procedure is effective and safe in subjects with longstanding persistent AF undergoing mitral valve repair or replacement.

Study objective: The study objectives were to characterize the safety and efficacy of the Medtronic Cardioblate CryoFlex Surgical Ablation System when used to treat subjects with longstanding persistent AF requiring concomitant mitral valve repair or replacement.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558635

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

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01558635     History of Changes
Other Study ID Numbers: MDT-CRYO-001
Study First Received: March 16, 2012
Last Updated: April 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):
Atrial Fibrillation
Surgical ablation
Maze procedure
AF

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 21, 2017