PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

Study Overview
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Brief Summary
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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
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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.

Official Title
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PreFER MVP for Elective Replacement

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: Managed Ventricular Pacing programmed ON/OFF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MVP ON<br>Managed Ventricular Pacing programmed on | Device: Managed Ventricular Pacing programmed ON/OFF<br>* Device programming<br>|
| Other: MVP OFF<br>Managed Ventricular Pacing programmed off: conventional pacing | Device: Managed Ventricular Pacing programmed ON/OFF<br>* Device programming<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 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. | Implant to 2 years post-implant | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker or ICD replacement