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

NCT01558635 | Terminated Results

• 1 other identifier: MDT-CRYO-001
• Study Type: interventional
• Target: 17
• Locations: 4 countries
• Sites: 4

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.

Conditions

Longstanding Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation; Surgical Ablation; Maze Procedure; AF

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

• 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

  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

  30 days

Secondary Outcomes (6)

• Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs

  12 Months

• Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs

  3 Months

• 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

• Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure

  6 and 12 months

Study Arms (1)

Cardioblate CryoFlex Surgical Ablation

EXPERIMENTAL

Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery. During surgery, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor future episodes of AF.

Device: Cardioblate CryoFlex Surgical Ablation; Procedure: Mitral Valve surgery; Device: Medtronic Reveal XT Insertable Cardiac Monitor; Procedure: MAZE III

Interventions

Cardioblate CryoFlex Surgical Ablation DEVICE

Longstanding persistent AF was treated with the Cox Cryo Maze III procedure During mitral valve surgery a surgical ablation was performed, using the Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.

Cardioblate CryoFlex Surgical Ablation

Mitral Valve surgery PROCEDURE

Classic mitral valve surgery was performed

Cardioblate CryoFlex Surgical Ablation

Medtronic Reveal XT Insertable Cardiac Monitor DEVICE

During the procedure, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor episodes of AF during follow-up period

Cardioblate CryoFlex Surgical Ablation

MAZE III PROCEDURE

Longstanding persistent AF was treated with the Cox Cryo Maze III procedure

Cardioblate CryoFlex Surgical Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (4)

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

San Raffaele Hospital

Milan, 20149, Italy

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Maze Procedure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Thoracic Surgical Procedures

Limitations and Caveats

Study was prematurely stopped due to sustained difficulties in the recruitment of eligible subjects. As a result only 17 subjects were enrolled in the study. Reveal XT data were retrievable in only 6 of the enrolled subjects.

Results Point of Contact

• Title: Ber Kleijnen, Sr Clinical Research Manager
• Organization: Medtronic, Bakken Research Center, Coronary and Structural Heart Disease Management (CSH), Endepolsdomein 5, 6229 GW Maastricht, The Netherlands

ber.kleijnen@medtronic.com

+31653227763

Study Officials

• Eric Vang, MD

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: November 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 30, 2019
• Results First Posted: March 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (1); IL (1); DE (1)