Cardiovascular Diseases
Conditions
Keywords
Pacemaker or ICD replacement
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.
Interventions
DEVICEManaged Ventricular Pacing programmed ON/OFF
Device programming
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 Use of Anticoagulation | Implant to 2 years post-implant | Endpoint: Use of Anticoagulation at enrollment and every follow-up visit |
| 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 |
| Incidence of High Voltage Therapies | Implant to 2 years post-implant | Endpoint: A high voltage therapy delivered |
| 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 |
| Number of Cardiovascular Related Hospitalizations | Implant to 4 years post-implant | Endpoint: Number of Cardiovascular hospitalizations per subject |
| 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 |
| 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 |
| Patient Symptoms | Implant to 2 years post-implant | Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup |
| Atrial Pacing Percentage | 2 years post-implant | Endpoint: Cumulative percentage atrial pacing documented in the device memory |
| 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 |
| 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. |
Countries
Netherlands
Participant flow
Recruitment details
Study start February 2006; last patient enrolled in August 2009.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| MVP ON Managed Ventricular Pacing programmed on | 299 |
| MVP OFF Managed Ventricular Pacing programmed off: conventional pacing | 306 |
| Total | 605 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 16 |
| Overall Study | Physician Decision | 23 | 17 |
| Overall Study | Withdrawal by Subject | 4 | 8 |
Baseline characteristics
| Characteristic | MVP ON | MVP OFF | Total |
|---|---|---|---|
| Age, Continuous | 75.1 years STANDARD_DEVIATION 10.9 | 74.3 years STANDARD_DEVIATION 10.8 | 74.7 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 125 Participants | 115 Participants | 240 Participants |
| Sex: Female, Male Male | 174 Participants | 191 Participants | 365 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 299 | 31 / 306 |
| serious Total, serious adverse events | 85 / 299 | 72 / 306 |
Outcome results
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: * 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 frame: Implant to 2 years post-implant
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MVP ON | Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant | 43 number of participants |
| MVP OFF | Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant | 40 number of participants |
Comparison: Analysis:Time to first cardiovascular hospitalization (CV hosp)~H0:freedom from CV hosp MVP=freedom from CV hosp DDD (dual chamber conventional pacing)~Ha:freedom from CV hosp MVP≠freedom from CV hosp DDD~Power calculation:~The study is designed to detect a difference event-free survival after 2 years of 5.5 % absolute, going from 91.5% to 97%.~Test=two-sided alpha=0.05 power=80% 1:1 randomization n=600p-value: 0.7295% CI: [0.612, 1.405]Log Rank
Secondary
Atrial Pacing Percentage
Endpoint: Cumulative percentage atrial pacing documented in the device memory
Time frame: 2 years post-implant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MVP ON | Atrial Pacing Percentage | 68 percentage atrial pacing |
| MVP OFF | Atrial Pacing Percentage | 78 percentage atrial pacing |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time
Endpoint: LVEF (%) difference between 2 year post implant and baseline
Time frame: Implant to 2 years post-implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MVP ON | Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time | -1.2 LVEF (%) difference | Standard Deviation 10.5 |
| MVP OFF | Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time | 1.4 LVEF (%) difference | Standard Deviation 9.5 |
p-value: 0.048Regression, Linear
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.
Time frame: Baseline, one year and 2 year post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class II (Baseline) | 108 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class II (12-months) | 97 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class IV (24-months) | 0 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class III (12-months) | 5 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class III (Baseline) | 19 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class IV (12-months) | 0 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | No Heart Failure (24-months) | 53 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class I (Baseline) | 99 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class I (24-months) | 68 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class IV (Baseline) | 1 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class II (24-months) | 83 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | No Heart Failure (Baseline) | 64 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class III (24-months) | 11 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | No Heart Failure (12-months) | 67 Participants |
| MVP ON | Change in New York Heart Association (NYHA) Functional Class | Class I (12-months) | 69 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class IV (24-months) | 1 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class IV (12-months) | 2 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | No Heart Failure (Baseline) | 92 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class I (Baseline) | 87 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class II (Baseline) | 108 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class III (Baseline) | 9 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class IV (Baseline) | 3 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class I (12-months) | 72 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class II (12-months) | 86 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class III (12-months) | 10 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | No Heart Failure (24-months) | 73 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class I (24-months) | 69 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class II (24-months) | 69 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | Class III (24-months) | 9 Participants |
| MVP OFF | Change in New York Heart Association (NYHA) Functional Class | No Heart Failure (12-months) | 71 Participants |
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
Time frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MVP ON | Change in PR Interval, Change in QRS Duration and Change in P-wave Duration | PR interval (ms) difference 24 month-baseline | 11.6 milliseconds | Standard Deviation 60.9 |
| MVP ON | Change in PR Interval, Change in QRS Duration and Change in P-wave Duration | QRS duration (ms) difference: 24 month-baseline | 2.6 milliseconds | Standard Deviation 32.4 |
| MVP ON | Change in PR Interval, Change in QRS Duration and Change in P-wave Duration | P-wave duration (ms) difference: 24 month-baseline | 5.2 milliseconds | Standard Deviation 41.2 |
| MVP OFF | Change in PR Interval, Change in QRS Duration and Change in P-wave Duration | PR interval (ms) difference 24 month-baseline | 10.8 milliseconds | Standard Deviation 63.6 |
| MVP OFF | Change in PR Interval, Change in QRS Duration and Change in P-wave Duration | QRS duration (ms) difference: 24 month-baseline | 10.8 milliseconds | Standard Deviation 41.8 |
| MVP OFF | Change in PR Interval, Change in QRS Duration and Change in P-wave Duration | P-wave duration (ms) difference: 24 month-baseline | 1.1 milliseconds | Standard Deviation 38.4 |
Comparison: H0:Change in P-R interval=Change in P-R interval Ha:Change in P-R interval≠Change in P-R intervalp-value: 0.34Wilcoxon (Mann-Whitney)
Comparison: H0:Change in QRS duration=Change in QRS duration Ha:Change in QRS duration≠Change in QRS durationp-value: 0.19Wilcoxon (Mann-Whitney)
Comparison: H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave durationp-value: 0.29Wilcoxon (Mann-Whitney)
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
Time frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Calcium antagonists (12-months), n=246, 257 | 46 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Antiarrhythmic drugs (12-months), n=246, 257 | 67 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Beta-blockers (Baseline), n=298, 304 | 129 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Digitalis/digoxin (Baseline), n=298, 304 | 26 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Calcium antagonists (Baseline), n=298, 304 | 54 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Antiarrhythmic drugs (Baseline), n=298, 304 | 81 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Beta-blockers (1-month), n=271, 285 | 117 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Digitalis/digoxin (1-month), n=271, 285 | 24 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Calcium antagonists (1-month), n=271, 285 | 49 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Antiarrhythmic drugs (1-month), n=271, 285 | 75 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Beta-blockers (12-months), n=246, 257 | 108 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Digitalis/digoxin (12-months), n=246, 257 | 22 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Beta-blockers (24-months), n=226, 231 | 104 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Digitalis/digoxin (24-months), n=226, 231 | 20 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Calcium antagonists (24-months), n=226, 231 | 36 participants |
| MVP ON | Change in the Use of Cardiovascular Medication Over Time | Antiarrhythmic drugs (24-month), n=226, 231 | 58 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Antiarrhythmic drugs (24-month), n=226, 231 | 76 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Calcium antagonists (12-months), n=246, 257 | 52 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Calcium antagonists (1-month), n=271, 285 | 60 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Antiarrhythmic drugs (12-months), n=246, 257 | 88 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Beta-blockers (24-months), n=226, 231 | 93 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Beta-blockers (Baseline), n=298, 304 | 116 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Antiarrhythmic drugs (1-month), n=271, 285 | 98 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Digitalis/digoxin (Baseline), n=298, 304 | 30 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Calcium antagonists (24-months), n=226, 231 | 47 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Calcium antagonists (Baseline), n=298, 304 | 63 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Beta-blockers (12-months), n=246, 257 | 105 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Antiarrhythmic drugs (Baseline), n=298, 304 | 103 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Digitalis/digoxin (24-months), n=226, 231 | 22 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Beta-blockers (1-month), n=271, 285 | 111 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Digitalis/digoxin (12-months), n=246, 257 | 26 participants |
| MVP OFF | Change in the Use of Cardiovascular Medication Over Time | Digitalis/digoxin (1-month), n=271, 285 | 28 participants |
Comparison: Analysis:Repeated measures logistic regression H0:Change in Beta-blockers=Change in Beta-blockers Ha:Change in Beta-blockers≠Change in Beta-blockersp-value: 0.34Regression, Logistic
Comparison: Analysis:Repeated measures logistic regression H0:Change in Digitalis/digoxin=Change in Digitalis/digoxin Ha:Change in Digitalis/digoxin≠Change in Digitalis/digoxinp-value: 0.65Regression, Logistic
Comparison: Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonistsp-value: 0.55Regression, Logistic
Comparison: Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drugp-value: 0.53Regression, Logistic
Secondary
Change in Use of Anticoagulation
Endpoint: Use of Anticoagulation at enrollment and every follow-up visit
Time frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Change in Use of Anticoagulation | Patients with Medication Records (Baseline) | 298 participants |
| MVP ON | Change in Use of Anticoagulation | Patients Using Anticoagulants (Baseline) | 75 participants |
| MVP ON | Change in Use of Anticoagulation | Patients with Medication Records (1-month) | 271 participants |
| MVP ON | Change in Use of Anticoagulation | Patients Changing Anticoagulants Use (1-month) | 24 participants |
| MVP ON | Change in Use of Anticoagulation | Patients with Medication Records (12-months) | 246 participants |
| MVP ON | Change in Use of Anticoagulation | Patients Changing Anticoagulants Use (12-months) | 28 participants |
| MVP ON | Change in Use of Anticoagulation | Patients with Medication Records (24-months) | 226 participants |
| MVP ON | Change in Use of Anticoagulation | Patients Changing Anticoagulants Use (24-months) | 27 participants |
| MVP OFF | Change in Use of Anticoagulation | Patients Changing Anticoagulants Use (24-months) | 33 participants |
| MVP OFF | Change in Use of Anticoagulation | Patients with Medication Records (Baseline) | 304 participants |
| MVP OFF | Change in Use of Anticoagulation | Patients with Medication Records (12-months) | 257 participants |
| MVP OFF | Change in Use of Anticoagulation | Patients Using Anticoagulants (Baseline) | 72 participants |
| MVP OFF | Change in Use of Anticoagulation | Patients with Medication Records (24-months) | 231 participants |
| MVP OFF | Change in Use of Anticoagulation | Patients with Medication Records (1-month) | 285 participants |
| MVP OFF | Change in Use of Anticoagulation | Patients Changing Anticoagulants Use (12-months) | 31 participants |
| MVP OFF | Change in Use of Anticoagulation | Patients Changing Anticoagulants Use (1-month) | 21 participants |
Comparison: Analysis:Repeated measures logistic regressionp-value: 0.78Repeated measures logistic regression
Secondary
Duration of Cardiovascular Related Hospitalizations
Endpoint: Duration of Cardiovascular Hospitalizations per subject
Time frame: Implant to 4 years post-implant
Population: All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MVP ON | Duration of Cardiovascular Related Hospitalizations | 7.0 Days of CV hospitalizations |
| MVP OFF | Duration of Cardiovascular Related Hospitalizations | 7.5 Days of CV hospitalizations |
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.
Time frame: 2 years post-implant
Population: Patients with health evaluation completed at 24 months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MVP ON | Health State | 70.6 units on a Health State scale | Standard Deviation 17.2 |
| MVP OFF | Health State | 70.3 units on a Health State scale | Standard Deviation 16.6 |
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
Time frame: Implant to 2 years post-implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MVP ON | Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients | 0 participants |
| MVP OFF | Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients | 0 participants |
Secondary
Incidence of High Voltage Therapies
Endpoint: A high voltage therapy delivered
Time frame: Implant to 2 years post-implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MVP ON | Incidence of High Voltage Therapies | 1 participants |
| MVP OFF | Incidence of High Voltage Therapies | 3 participants |
Secondary
Number of Cardiovascular Related Hospitalizations
Endpoint: Number of Cardiovascular hospitalizations per subject
Time frame: Implant to 4 years post-implant
Population: All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MVP ON | Number of Cardiovascular Related Hospitalizations | 1.0 Number of CV Hospitalizations |
| MVP OFF | Number of Cardiovascular Related Hospitalizations | 1.0 Number of CV Hospitalizations |
Comparison: Statistical test for Number of subjects with CV hospitalizationp-value: 0.83Wilcoxon (Mann-Whitney)
Secondary
Patient Symptoms
Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup
Time frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Patient Symptoms | No symptoms (baseline) | 175 participants |
| MVP ON | Patient Symptoms | Chest pain (baseline) | 24 participants |
| MVP ON | Patient Symptoms | Dyspnea (baseline) | 65 participants |
| MVP ON | Patient Symptoms | Dizziness/presyncope (baseline) | 32 participants |
| MVP ON | Patient Symptoms | No Symptoms (12 months) | 175 participants |
| MVP ON | Patient Symptoms | Chest pain (12 months) | 11 participants |
| MVP ON | Patient Symptoms | Dizziness/presyncope (12 months) | 9 participants |
| MVP ON | Patient Symptoms | No Symptoms (24 months) | 158 participants |
| MVP ON | Patient Symptoms | Chest pain (24 months | 15 participants |
| MVP ON | Patient Symptoms | Dyspnea (24 months) | 39 participants |
| MVP ON | Patient Symptoms | Dizziness/presyncope (24 months) | 8 participants |
| MVP ON | Patient Symptoms | Dyspnea (12 months) | 36 participants |
| MVP OFF | Patient Symptoms | Dizziness/presyncope (24 months) | 15 participants |
| MVP OFF | Patient Symptoms | No symptoms (baseline) | 193 participants |
| MVP OFF | Patient Symptoms | Dizziness/presyncope (12 months) | 17 participants |
| MVP OFF | Patient Symptoms | Chest pain (baseline) | 15 participants |
| MVP OFF | Patient Symptoms | Dyspnea (24 months) | 40 participants |
| MVP OFF | Patient Symptoms | Dyspnea (baseline) | 59 participants |
| MVP OFF | Patient Symptoms | No Symptoms (24 months) | 160 participants |
| MVP OFF | Patient Symptoms | Dizziness/presyncope (baseline) | 27 participants |
| MVP OFF | Patient Symptoms | Dyspnea (12 months) | 38 participants |
| MVP OFF | Patient Symptoms | No Symptoms (12 months) | 184 participants |
| MVP OFF | Patient Symptoms | Chest pain (24 months | 10 participants |
| MVP OFF | Patient Symptoms | Chest pain (12 months) | 12 participants |
Comparison: No Symptoms (Baseline)p-value: 0.24Fisher Exact
Comparison: No Symptoms (12 months)p-value: 0.92Fisher Exact
Comparison: No Symptoms (24 Months)p-value: 1Fisher Exact
Secondary
Stroke
Endpoint: Stroke
Time frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Stroke | Stroke at 1 year | 3 participants |
| MVP ON | Stroke | Stroke at 2 years | 4 participants |
| MVP OFF | Stroke | Stroke at 1 year | 4 participants |
| MVP OFF | Stroke | Stroke at 2 years | 6 participants |
p-value: 0.2495% CI: [0.148, 1.637]Log Rank
Secondary
Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant
Time to patient death from any cause
Time frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant | All-Cause Death at 1 year | 17 participants |
| MVP ON | Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant | All-Cause Death at 2 years | 31 participants |
| MVP OFF | Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant | All-Cause Death at 1 year | 7 participants |
| MVP OFF | Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant | All-Cause Death at 2 years | 22 participants |
Comparison: Analysis:Time to all-cause death~H0:survival MVP ON=survival MVP OFF Ha:survival MVP ON≠survival MVP OFFp-value: 0.3395% CI: [0.803, 1.923]Log Rank
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
Time frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant. | Death or CV hospitalization at 1 year | 33 participants |
| MVP ON | Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant. | Death or CV hospitalization at 2 years | 66 participants |
| MVP OFF | Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant. | Death or CV hospitalization at 1 year | 30 participants |
| MVP OFF | Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant. | Death or CV hospitalization at 2 years | 57 participants |
Comparison: Analysis:Time to first all cause death or cardiovascular hospitalization~H0:freedom from death or CV hospitalization=freedom from death or CV hospitalization~Ha:freedom from death or CV hospitalization≠freedom from death or CV hospitalizationp-value: 0.4895% CI: [0.808, 1.57]Log Rank
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: * 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
Time frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant | Permanent AF at 1 year | 8 participants |
| MVP ON | Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant | Permanent AF at 2 years | 11 participants |
| MVP OFF | Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant | Permanent AF at 1 year | 3 participants |
| MVP OFF | Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant | Permanent AF at 2 years | 8 participants |
Comparison: Analysis:Time to permanent AF H0:freedom from permanent AF=freedom from permanent AF Ha:freedom from permanent AF≠freedom from permanent AFp-value: 0.4495% CI: [0.573, 3.543]Log Rank
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: * 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 frame: Implant to 2 years post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MVP ON | Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant | Persistent AT/AF at 1 year | 27 participants |
| MVP ON | Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant | Persistent AT/AF at 2 years | 41 participants |
| MVP OFF | Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant | Persistent AT/AF at 1 year | 17 participants |
| MVP OFF | Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant | Persistent AT/AF at 2 years | 30 participants |
Comparison: Analysis:Time to first persistent AT/AF H0:freedom from persistent AT/AF=freedom from persistent AT/AF Ha:freedom from persistent AT/AF≠freedom from persistent AT/AFp-value: 0.0895% CI: [0.954, 2.424]Log Rank
Secondary
Ventricular Pacing Percentage
Endpoint: Cumulative percentage ventricular pacing documented in the device memory
Time frame: Implant to 2 years post-implant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MVP ON | Ventricular Pacing Percentage | 5 Percentage Ventricular Pacing |
| MVP OFF | Ventricular Pacing Percentage | 86 Percentage Ventricular Pacing |
Comparison: Analysis:Wilcoxon Test for Comparison of Percentage of Ventricular Pacing (%VP) During Followup by Randomization Arm~H0:distribution %VP MVP=distribution %VP DDD~Ha:distribution %VP MVP≠distribution %VP DDD~Ha:p-value: <0.0001Wilcoxon (Mann-Whitney)