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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVP ON | Other | Managed Ventricular Pacing programmed on |
|
| MVP OFF | Other | Managed Ventricular Pacing programmed off: conventional pacing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Managed Ventricular Pacing programmed ON/OFF | Device | Device programming |
|
| 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:
Cardiovascular is defined as new or worsening:
| Implant to 2 years post-implant |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Piot, Dr. | Centre Cardiologique du Nord, Saint-Denis, France | Principal Investigator |
| Aurelio Quesada, Dr. | Hospital General Universitario de Valencia, Spain | Principal Investigator |
| De Roy, Prof. | Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium | Principal Investigator |
| Renato Ricci, Dr. | San Filippo Neri Hospital, Rome, Italy | Principal Investigator |
| Gianluca Botto, Dr. | Como S. Anna Hospital, Como, Italy | Principal Investigator |
| Milan Kozak, Dr. | Fakultní nemocnice Brno Bohunice, Brno, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medtronic Bakken Research Center | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26142300 | Derived | Ricci RP, Botto GL, Benezet JM, Nielsen JC, De Roy L, Piot O, Quesada A, Quaglione R, Vaccari D, Mangoni L, Grammatico A, Kozak M; PreFER MVP Investigators. Association between ventricular pacing and persistent atrial fibrillation in patients indicated to elective pacemaker replacement: Results of the Prefer for Elective Replacement MVP (PreFER MVP) randomized study. Heart Rhythm. 2015 Nov;12(11):2239-46. doi: 10.1016/j.hrthm.2015.06.041. Epub 2015 Jun 30. |
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Patients were electronically randomized. 25 patients were excluded from analysis due to double entry (7) or no evidence of Patient Informed Consent Form (PIC) signed (18).
Study start February 2006; last patient enrolled in August 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | MVP ON | Managed Ventricular Pacing programmed on |
| FG001 | MVP OFF | Managed Ventricular Pacing programmed off: conventional pacing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MVP ON | Managed Ventricular Pacing programmed on |
| BG001 | MVP OFF | Managed Ventricular Pacing programmed off: conventional pacing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
Cardiovascular is defined as new or worsening:
| Patients indicated for Implantable Pulse Generator (IPG) or Implantable Cardioverter Defibrillator (ICD) replacement with a history of right ventricular pacing > 40%, to be allocated to either Managed Ventricular Pacing (MVP) programming, or conventional dual chamber programming (DDD) without MVP | Posted | Number | number of participants | Implant to 2 years post-implant |
|
Adverse events were collected from baseline until study closure. The following abbreviations are used in the additional description: SAE: serious adverse event. (S)ADE: (serious) adverse device effect. PE: primary endpoint.
The following adverse events had to be reported:
The PE committee adjudicated all reported AEs per the primary objective. No further classification has been done.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MVP ON | Managed Ventricular Pacing programmed on |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| First cardiovascular hospitalization within 2 years after implant | Cardiac disorders | Non-systematic Assessment | Hospitalization (including emergency room) for cardiovascular causes: new or worsening heart failure, angina, myocardial infarction, any arrhythmia, stroke, transient ischemic attack, acute peripheral vascular emergencies, pulmonary embolism. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non serious adverse events up to 2 years follow-up | General disorders | Non-systematic Assessment | All reported adverse events which were not serious |
Atrial pacing % was not collected at implant, device programming in the MVP off arm was more often non-compliant than in MVP on arm, and 25% of the case report forms were sent without device data, possibly influencing device data related objectives
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lidwien Vainer | Medtronic Bakken | +31 433566752 | lidwien.vainer@medtronic.com |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:
|
| 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:
| 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 |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MVP ON |
Managed Ventricular Pacing programmed on |
| OG001 | MVP OFF | Managed Ventricular Pacing programmed off: conventional pacing |
|
|
|
| Secondary | 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 | Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
|
| Secondary | 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:
| Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
|
| Secondary | 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:
| Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
|
| Secondary | Ventricular Pacing Percentage | Endpoint: Cumulative percentage ventricular pacing documented in the device memory | Posted | Median | Inter-Quartile Range | Percentage Ventricular Pacing | Implant to 2 years post-implant |
|
|
|
|
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time | Endpoint: LVEF (%) difference between 2 year post implant and baseline | Posted | Mean | Standard Deviation | LVEF (%) difference | Implant to 2 years post-implant |
|
|
|
|
| Secondary | 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. | Posted | Number | Participants | Baseline, one year and 2 year post-implant |
|
|
|
| Secondary | Change in Use of Anticoagulation | Endpoint: Use of Anticoagulation at enrollment and every follow-up visit | Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
|
| Secondary | 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 | Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
|
| Secondary | Incidence of High Voltage Therapies | Endpoint: A high voltage therapy delivered | Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
| Secondary | Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant | Time to patient death from any cause | Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
|
| Secondary | Stroke | Endpoint: Stroke | Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
|
| Secondary | Number of Cardiovascular Related Hospitalizations | Endpoint: Number of Cardiovascular hospitalizations per subject | All participants were followed for 4 years. Those not hospitalized were excluded from the analysis. | Posted | Median | Inter-Quartile Range | Number of CV Hospitalizations | Implant to 4 years post-implant |
|
|
|
|
| Secondary | Duration of Cardiovascular Related Hospitalizations | Endpoint: Duration of Cardiovascular Hospitalizations per subject | All participants were followed for 4 years. Those not hospitalized were excluded from the analysis. | Posted | Median | Inter-Quartile Range | Days of CV hospitalizations | Implant to 4 years post-implant |
|
|
|
| Secondary | 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 | Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | milliseconds | Implant to 2 years post-implant |
|
|
|
|
| Secondary | Patient Symptoms | Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup | Posted | Number | participants | Implant to 2 years post-implant |
|
|
|
|
| Secondary | Atrial Pacing Percentage | Endpoint: Cumulative percentage atrial pacing documented in the device memory | Posted | Median | Inter-Quartile Range | percentage atrial pacing | 2 years post-implant |
|
|
|
|
| Secondary | 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. | Patients with health evaluation completed at 24 months follow-up | Posted | Mean | Standard Deviation | units on a Health State scale | 2 years post-implant |
|
|
|
| 85 |
| 299 |
| 32 |
| 299 |
| EG001 | MVP OFF | Managed Ventricular Pacing programmed off: conventional pacing | 72 | 306 | 31 | 306 |
|
| Cardioversion within 2 years after implant | Cardiac disorders | Non-systematic Assessment | Cardioversion medically or electrically |
|
| Stroke within 2 years after implant | Nervous system disorders | Non-systematic Assessment | Stroke |
|
| Death from any cause within 2 years after implant | General disorders | Non-systematic Assessment | All cause death |
|
|
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| Class II (Baseline) |
|
| Class III (Baseline) |
|
| Class IV (Baseline) |
|
| No Heart Failure (12-months) |
|
| Class I (12-months) |
|
| Class II (12-months) |
|
| Class III (12-months) |
|
| Class IV (12-months) |
|
| No Heart Failure (24-months) |
|
| Class I (24-months) |
|
| Class II (24-months) |
|
| Class III (24-months) |
|
| Class IV (24-months) |
|
| Patients with Medication Records (1-month) |
|
| Patients Changing Anticoagulants Use (1-month) |
|
| Patients with Medication Records (12-months) |
|
| Patients Changing Anticoagulants Use (12-months) |
|
| Patients with Medication Records (24-months) |
|
| Patients Changing Anticoagulants Use (24-months) |
|
| Calcium antagonists (Baseline), n=298, 304 |
|
| Antiarrhythmic drugs (Baseline), n=298, 304 |
|
| Beta-blockers (1-month), n=271, 285 |
|
| Digitalis/digoxin (1-month), n=271, 285 |
|
| Calcium antagonists (1-month), n=271, 285 |
|
| Antiarrhythmic drugs (1-month), n=271, 285 |
|
| Beta-blockers (12-months), n=246, 257 |
|
| Digitalis/digoxin (12-months), n=246, 257 |
|
| Calcium antagonists (12-months), n=246, 257 |
|
| Antiarrhythmic drugs (12-months), n=246, 257 |
|
| Beta-blockers (24-months), n=226, 231 |
|
| Digitalis/digoxin (24-months), n=226, 231 |
|
| Calcium antagonists (24-months), n=226, 231 |
|
| Antiarrhythmic drugs (24-month), n=226, 231 |
|
| Regression, Logistic |
| 0.65 |
| 2-Sided |
| No |
| Superiority or Other |
| Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonists | Regression, Logistic | 0.55 | 2-Sided | No | Superiority or Other |
| Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drug | Regression, Logistic | 0.53 | 2-Sided | No | Superiority or Other |
| P-wave duration (ms) difference: 24 month-baseline |
|
| Wilcoxon (Mann-Whitney) |
| 0.19 |
| 2-Sided |
| No |
| Superiority or Other |
| H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave duration | Wilcoxon (Mann-Whitney) | 0.29 | 2-Sided | No | Superiority or Other |
| Dyspnea (baseline) |
|
| Dizziness/presyncope (baseline) |
|
| No Symptoms (12 months) |
|
| Chest pain (12 months) |
|
| Dyspnea (12 months) |
|
| Dizziness/presyncope (12 months) |
|
| No Symptoms (24 months) |
|
| Chest pain (24 months |
|
| Dyspnea (24 months) |
|
| Dizziness/presyncope (24 months) |
|
| 0.92 |
| 2-Sided |
| No |
| Superiority or Other |
| No Symptoms (24 Months) | Fisher Exact | 1.0 | 2-Sided | No | Superiority or Other |