Mintek Pacemaker LV-T Manuel d'utilisateur télécharger pdf (Page 27)

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

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Mintek Pacemaker LV-T Manuel d'utilisateur Page 27