Phase 3
N=381
MultiPoint Pacing IDE Study
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01786993 ↗Enrolled (actual)
381
Serious AEs
1.8%
Results posted
Sep 2016
Primary outcome: Primary: Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion — 0.932 Event-Free Probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MultiPoint Pacing (Device); Traditional Biventricular Pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion |
0.932 | — |
| PRIMARY Percentage of Non-responders With MPP Compared to Biventricular Pacing |
29.9; 25 | 0.0131 sig |
Summary
This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.
The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.
Eligibility Criteria
Inclusion Criteria
- Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)
- Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
- Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria
- Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment
- Have an existing Class I recalled lead
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
- Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months
- Have permanent atrial fibrillation (AF)
- Have undergone a cardiac transplantation within 40 days of enrollment
- Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant.
- Are currently participating in a clinical investigation that includes an active treatment arm
- Are pregnant or planning to become pregnant during the duration of the study
- Have a life expectancy of less than 9 months due to any condition
- Are less than 18 years of age
Data sourced from ClinicalTrials.gov (NCT01786993). 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.