Health TrialsbyHealthPanel

Medtronic Terminate AF Study

ConditionsPersistent Atrial FibrillationLongstanding Persistent Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Cardiac Surgery

About this trial

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of non-paroxysmal AF (persistent or longstanding persistent)

Concomitant indication for non-emergent open-heart surgery, eg,

Coronary artery bypass grafting

Valve repair or replacement

Disqualifiers

Wolff-Parkinson-White syndrome

New York Heart Association (NYHA) Class = IV

Left Ventricular Ejection Fraction ≤ 30%

Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery

Trial design

Design model

Single group

Treatments tested in this trial

  • Surgical Ablation

    Procedure/Surgery

    In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.

  • Cardioblate and Cryoflex hand held devices

    Device

    The Cardioblate hand held devices consist of the Cardioblate iRF and Cryoflex surgical ablation devices.

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: Primary CohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Composite acute major adverse event rate

Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death.

Time frame
30-days post-procedure or hospital discharge (whichever is longer)
2

Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)

Freedom from AF/AFL/AT of 30 seconds or greater duration on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy.

Time frame
6-months post-procedure to 12-months post-procedure

Secondary outcomes

1

Composite acute major adverse event rate (Safety)

Composite acute major adverse event rate at 6 months post-procedure (as defined above)

Time frame
6-months post-procedure
2

Composite acute major adverse event rate (Safety)

Composite acute major adverse event rate at 12 months post-procedure (as defined above)

Time frame
12-months post-procedure
3

Percentage of new permanent pacemaker implantation (Safety)

Percentage of new permanent pacemaker implantation presented by indication

Time frame
12-months post-procedure
4

Acute procedural success (Efficacy)

Acute procedural success (pulmonary vein isolation)

Time frame
During index procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Cardiac Surgery

Lead sponsor

Source ClinicalTrials.gov
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