Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation

Not Applicable

Terminated

Conditions: Longstanding Persistent Atrial Fibrillation

Registration Number: NCT01558635

Lead Sponsor: Medtronic Bakken Research Center

Brief Summary: 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 clinical evidence that the Cardioblate System is safe and effective to treat AF.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 17

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	12 months	The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden \< 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period.
Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last	30 days	The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention

Secondary Outcome Measures

Name	Time	Method
Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure	6 and 12 months	The 12-Item Short Form Health Survey (SF-12) is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Ten summary scores are reported from the SF-12. The scale range for each of the ten subscales is from 0 to 100, with higher scores corresponding to a better outcome. Subjects average unit score (with standard deviation) are reported at baseline, 6 and 12 months. As unit of measure we used units on a scale.
Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs	6 Months
AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months	3, 6 and 12 Months	AF burden is defined as percentage of time the patient is in AF during 24 hours.
Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last	12 months	The composite MAE was defined as a subject experiencing any of the following adverse events: * Stroke * Transient ischemic attack (TIA) * Pulmonary embolism * Peripheral arterial embolism * Myocardial infarction (MI) * Mediastinitis * Esophageal injury * Death * Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention

Trial Locations

Locations (4): Herzzentrum Leipzig GmbH
🇩🇪
Leipzig, Germany
Sheba Medical Center
🇮🇱
Tel-Hashomer, Israel
San Raffaele Hospital
🇮🇹
Milan, Italy
Hospital Clinic de Barcelona
🇪🇸
Barcelona, Spain
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany