Phase 4
N=605
PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00293241 ↗Enrolled (actual)
605
Serious AEs
26.0%
Results posted
Jun 2015
Primary outcome: Primary: Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant — 43; 40 number of participants — p=0.72
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Managed Ventricular Pacing programmed ON/OFF (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant |
43; 40 | 0.72 |
| SECONDARY Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant. |
33; 30; 66; 57 | 0.48 |
| SECONDARY Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant |
27; 17; 41; 30 | 0.08 |
| SECONDARY Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant |
8; 3; 11; 8 | 0.44 |
| SECONDARY Ventricular Pacing Percentage |
5; 86 | <0.0001 sig |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time |
-1.2; 1.4 | 0.048 sig |
| SECONDARY Change in New York Heart Association (NYHA) Functional Class |
64; 92; 99; 87; 108; 108 | — |
| SECONDARY Change in Use of Anticoagulation |
298; 304; 75; 72; 271; 285 | 0.78 |
| SECONDARY Change in the Use of Cardiovascular Medication Over Time |
129; 116; 26; 30; 54; 63 | 0.34 |
| SECONDARY Incidence of High Voltage Therapies |
1; 3 | — |
| SECONDARY Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant |
17; 7; 31; 22 | 0.33 |
| SECONDARY Stroke |
3; 4; 4; 6 | 0.24 |
| SECONDARY Number of Cardiovascular Related Hospitalizations |
1.0; 1.0 | 0.83 |
| SECONDARY Duration of Cardiovascular Related Hospitalizations |
7.0; 7.5 | — |
| SECONDARY Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients |
0; 0 | — |
| SECONDARY Change in PR Interval, Change in QRS Duration and Change in P-wave Duration |
11.6; 10.8; 2.6; 10.8; 5.2; 1.1 | 0.34 |
| SECONDARY Patient Symptoms |
175; 193; 24; 15; 65; 59 | 0.24 |
| SECONDARY Atrial Pacing Percentage |
68; 78 | 0.03 sig |
| SECONDARY Health State |
70.6; 70.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00293241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.