PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

Phase 4

Completed

Conditions: Cardiovascular Diseases

Interventions: Device: Managed Ventricular Pacing programmed ON/OFF

Registration Number: NCT00293241

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary: The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.

Detailed Description: A number of clinical studies (Danish I, Danish II, David, MOST) over the past few years have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can cause a variety of detrimental effects, including atrial fibrillation (AF), left ventricular (LV) dysfunction, and congestive heart failure (CHF). These effects are believed to result from the mechanical dyssynchrony and ventricular chamber dysfunction that occurs with chronic, single-site, apical ventricular stimulation.

Therefore a new pacing modality, Managed Ventricular Pacing (MVP), was designed to give preference to natural heart activity by minimizing unnecessary right ventricular pacing. This is accomplished by automatically switching between single chamber atrial and dual-chamber pacing based on specific patient needs.

MVP is an atrial-based dual-chamber pacing mode that provides functional AAI/R pacing with ventricular monitoring and back-up DDD/R pacing only as needed during episodes of AV block.

The reversibility of the detrimental effects caused by ventricular pacing has been initially investigated in small patient populations with short pacing durations in AAI and needs further investigation.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 630

Inclusion Criteria

Patients implanted with a dual chamber device (including atrial synchronous ventricular inhibited [VDD]) for a minimum time duration of 2 years
Planned to be replaced or replaced with a device including the MVP feature
Have had more than 40% ventricular pacing documented with their old device over a period of at least 4 weeks before enrollment or device replacement.
Pacing should not be caused by a switch to the single chamber pacing (VVI) mode because of battery depletion
Have signed the informed consent
Have no need to change the pacing mode or the atrioventricular (AV) intervals.

Exclusion Criteria

Patients with a cardiac resynchronization therapy (CRT) indication
Permanent AF
Permanent AV block
Inability to complete follow-up visits at a study center.
Unwillingness or inability to cooperate or give written informed consent, or the patient is a minor, and legal guardian refuses to give informed consent
Planned cardiovascular intervention
Inclusion in another clinical trial that will affect the objectives of this study
Neurocardiogenic syncope as primary implantable pulse generator (IPG) indication.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MVP OFF	Managed Ventricular Pacing programmed ON/OFF	Managed Ventricular Pacing programmed off: conventional pacing
MVP ON	Managed Ventricular Pacing programmed ON/OFF	Managed Ventricular Pacing programmed on

Primary Outcome Measures

Name	Time	Method
Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant	Implant to 2 years post-implant	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.

Secondary Outcome Measures

Name	Time	Method
Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.	Implant to 2 years post-implant	Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant
Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant	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 Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant	Implant to 2 years post-implant	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
Ventricular Pacing Percentage	Implant to 2 years post-implant	Endpoint: Cumulative percentage ventricular pacing documented in the device memory
Incidence of High Voltage Therapies	Implant to 2 years post-implant	Endpoint: A high voltage therapy delivered
Patient Symptoms	Implant to 2 years post-implant	Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup
Health State	2 years post-implant	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.
Change in New York Heart Association (NYHA) Functional Class	Baseline, one year and 2 year post-implant	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.
Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time	Implant to 2 years post-implant	Endpoint: LVEF (%) difference between 2 year post implant and baseline
Change in Use of Anticoagulation	Implant to 2 years post-implant	Endpoint: Use of Anticoagulation at enrollment and every follow-up visit
Number of Cardiovascular Related Hospitalizations	Implant to 4 years post-implant	Endpoint: Number of Cardiovascular hospitalizations per subject
Change in the Use of Cardiovascular Medication Over Time	Implant to 2 years post-implant	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
Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant	Implant to 2 years post-implant	Time to patient death from any cause
Stroke	Implant to 2 years post-implant	Endpoint: Stroke
Change in PR Interval, Change in QRS Duration and Change in P-wave Duration	Implant to 2 years post-implant	Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU
Duration of Cardiovascular Related Hospitalizations	Implant to 4 years post-implant	Endpoint: Duration of Cardiovascular Hospitalizations per subject
Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients	Implant to 2 years post-implant	Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication
Atrial Pacing Percentage	2 years post-implant	Endpoint: Cumulative percentage atrial pacing documented in the device memory