PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.

Hospitalization is defined as:

• admission to hospital involving one overnight stay or
• emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition

Cardiovascular is defined as new or worsening:

• heart failure (HF),
• angina,
• myocardial infarction (MI),
• any arrhythmia,
• stroke,
• transient ischemic attack (TIA),
• acute peripheral vascular emergencies,
• pulmonary embolism.

Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant

Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:

• 7 days in a row with device diagnostic showing 20 or more hours in AT/AF or
• a cardioversion was done to terminate AT/AF or
• the patient is during 2 consecutive follow-up (FU) visits in AT/AF

Time to development of permanent AF fulfilling one of the following criteria:

• 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or
• 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient

Endpoint: Cumulative percentage ventricular pacing documented in the device memory

Endpoint: LVEF (%) difference between 2 year post implant and baseline

Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.

II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.

III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.

IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases.

Endpoint: Use of Anticoagulation at enrollment and every follow-up visit

Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant

Endpoint: A high voltage therapy delivered

Time to patient death from any cause

Endpoint: Stroke

Endpoint: Number of Cardiovascular hospitalizations per subject

Endpoint: Duration of Cardiovascular Hospitalizations per subject

Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication

Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU

Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup

Endpoint: Cumulative percentage atrial pacing documented in the device memory

Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.