Mintek Pacemaker LV-T Manuel d'utilisateur télécharger pdf (Page 48)

40 Stratos LV/LV-T Technical Manual

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 bi-ventricular pacing

• Age ≥ 18 years

• Receiving optimal drug therapy for Congestive Heart

Failure treatment

• Give informed consent

Clinical Exclusion Criteria

To support the objectives of this investigation, the exclusion

criteria at the time of patient enrollment included the following

requirements:

• Myocardial infarction or unstable angina pectoris

• Acute myocarditis

• Life expectancy ≤ 6 months

• Planned cardiac surgical procedures or interventional

measures within the next 6 months

• Pregnancy

Follow-Up Schedule

All patients were implanted with the Corox OTW/Steroid LV lead

system and a CRT-P or CRT-D pulse generator capable of

providing bi-ventricular pacing for the treatment of CHF. The

specific study procedures were performed at:

• Pre-operative Visit

• Implantation

• Pre-discharge follow-up

• One-month follow-up

• Three-month follow-up

• Six-month follow-up

• Twelve-month follow-up

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Mintek Pacemaker LV-T Manuel d'utilisateur Page 48