Clinical trial NCT01558635: Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Official title: Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Subjects With Longstanding Persistent Atrial Fibrillation Requiring Mitral Valve Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Longstanding Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Surgical Ablation
Maze Procedure
AF
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
measure: 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
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
timeFrame: 12 Months
measure: Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
timeFrame: 3 Months
measure: Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs
timeFrame: 6 Months
measure: AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months
timeFrame: 3, 6 and 12 Months
measure: Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure
timeFrame: 6 and 12 months
measure: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last
timeFrame: 12 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Medtronic
name: Eric Vang, MD
role: STUDY_DIRECTOR
References: