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

This study is currently recruiting participants.
Verified October 2012 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01558635
First received: March 16, 2012
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  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 Phase
Longstanding Persistent Atrial Fibrillation
 Device: Medtronic Cardioblate CryoFlex
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cryo-AF Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558635

Contacts
Contact: Pascal Smeets +31(0)433566671 pascal.smeets@medtronic.com

Locations
Italy
San Raffaele Hospital Recruiting
Milan, Italy, 20149
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

No publications provided

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: October 9, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by 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 May 22, 2013