Medtronic Terminate AF Study
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
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
Treatments tested in this trial
- Surgical Ablation
- Cardioblate and Cryoflex hand held devices
Treatment groups
160 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov