Back to resultsMultiPoint Pacing Programming Guided by Noninvasive Hemodynamics
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CRT with MultiPoint Pacing
Hemodynamic measurements for CRT device programming
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system
- Be in NYHA II or III functional class with approved standard indication by ESC/EHRA Guidelines
- Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule
Exclusion Criteria:
- Have persistent or permanent atrial fibrillation
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months
- Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment
- Have had intravenous inotropic support in the last 30 days
- Be scheduled or considered for heart transplantation over the next 12 months
- Be less than 18 years of age
- Be pregnant or plan to become pregnant over the next 12 months
Sites / Locations
- Medizinische Universität Graz
- CHU Rennes
- Niguarda Hospital
- Fondazione IRCCS Policlinico San Matteo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MultiPoint Pacing
Arm Description
CRT with MultiPoint Pacing
Outcomes
Primary Outcome Measures
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
Secondary Outcome Measures
echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements
End systolic volume will be assessed at 6-month follow-up visit and compared to that of baseline.
Full Information
NCT ID
NCT02064751
First Posted
February 14, 2014
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT02064751
Brief Title
MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics
Official Title
Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MultiPoint Pacing
Arm Type
Experimental
Arm Description
CRT with MultiPoint Pacing
Intervention Type
Device
Intervention Name(s)
CRT with MultiPoint Pacing
Intervention Type
Procedure
Intervention Name(s)
Hemodynamic measurements for CRT device programming
Primary Outcome Measure Information:
Title
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
Time Frame
up to 6-months
Secondary Outcome Measure Information:
Title
echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements
Description
End systolic volume will be assessed at 6-month follow-up visit and compared to that of baseline.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system
Be in NYHA II or III functional class with approved standard indication by ESC/EHRA Guidelines
Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule
Exclusion Criteria:
Have persistent or permanent atrial fibrillation
Have a recent myocardial infarction within 40 days prior to enrollment
Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months
Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment
Have had intravenous inotropic support in the last 30 days
Be scheduled or considered for heart transplantation over the next 12 months
Be less than 18 years of age
Be pregnant or plan to become pregnant over the next 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Leclercq, MD, PhD
Organizational Affiliation
University Hospital Rennes, Rennes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Graz
City
Graz
Country
Austria
Facility Name
CHU Rennes
City
Rennes
Country
France
Facility Name
Niguarda Hospital
City
Milan
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
12. IPD Sharing Statement
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MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics
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