MultiPoint Pacing IDE Study (MPP IDE)
This study is currently recruiting participants.
Verified May 2013 by St. Jude Medical
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01786993
First received: February 6, 2013
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with multi-point pacing compared to patient treatment with standard Biventricular 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 patients implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Device: MultiPoint Pacing Device: Traditional Biventricular Pacing |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | MultiPoint Pacing IDE Study |
Resource links provided by NLM:
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Freedom from system-related complications [ Time Frame: 9-Month ] [ Designated as safety issue: Yes ]
- Percentage of non-responders with multi-point pacing compared to biventricular pacing [ Time Frame: 9-Month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 506 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Multi-point pacing arm
MultiPoint Pacing
|
Device: MultiPoint Pacing |
|
Active Comparator: Biventricular arm
Traditional Biventricular Pacing
|
Device: Traditional Biventricular Pacing |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 cardiac resynchronization therapy device implant
- 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 implantable cardioverter defibrillator system or pacemaker system
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786993
Contacts
| Contact: Kwangdeok Lee, PhD | 818-493-2522 |
Locations
| United States, Texas | |
| Cardiology Center of Amarillo, L.L.P | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Coty Jewell, MD | |
| Principal Investigator: Coty Jewell, MD | |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Principal Investigator: | Gery Tomassoni, MD | Central Baptist Hospital |
More Information
No publications provided
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01786993 History of Changes |
| Other Study ID Numbers: | 60029161/D |
| Study First Received: | February 6, 2013 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013