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Stratos LV/LV-T Technical Manual 19
Clinical Inclusion Criteria
To support the objectives of this investigation, patients were
required to meet the following inclusion criteria prior to
enrollment:
• Meet the indications for therapy
• Persistent (documented for more than 7 days),
symptomatic AF with poorly controlled rapid ventricular
rates or permanent, (documented for more than 30 days
with failed cardioversion, or longstanding AF of 6 months
or more) symptomatic AF with poorly controlled rapid
ventricular rates.
• Eligible for AV nodal ablation and permanent pacemaker
implantation
• NYHA Class II or III heart failure
• Age ≥ 18 years
• Understand the nature of the procedure
• Ability to tolerate the surgical procedure required for
implantation
• Give informed consent
• Able to complete all testing required by the clinical
protocol
• Available for follow-up visits on a regular basis at the
investigational site