Heart FailureNCT02064751
MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics
A study testing CRT with MultiPoint Pacing and Hemodynamic measurements for CRT device programming in people with Heart Failure, run by Abbott Medical Devices at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT with MultiPoint Pacing and Hemodynamic measurements for CRT device programming
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Mar 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Italy2 sites
Niguarda Hospital
Milan
Fondazione IRCCS Policlinico San Matteo
Pavia
About this study
Official title: Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients
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).
- Conditions
- Heart Failure
- Being tested
- CRT with MultiPoint Pacing, Hemodynamic measurements for CRT device programming
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT with MultiPoint PacingDevice
Hemodynamic measurements for CRT device programmingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MultiPoint Pacing | Experimental | CRT with MultiPoint Pacing Receives: Device: CRT with MultiPoint Pacing; Procedure: Hemodynamic measurements for CRT device programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
Measured: up to 6-months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Leclercq, MD, PhD, Principal investigator, University Hospital Rennes, Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064751
- Sponsor's protocol ID
- CRD_704
- Status last verified
- Jan 2019
- First submitted
- 14 Feb 2014
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients
- ClinicalTrials.gov ID
- NCT02064751
- Acronym / sponsor ID
- CRD_704
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MultiPoint Pacing | Experimental | Device: CRT with MultiPoint Pacing, Procedure: Hemodynamic measurements for CRT device programmingCRT with MultiPoint Pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT with MultiPoint Pacing | Device | MultiPoint Pacing |
| Hemodynamic measurements for CRT device programming | Procedure or surgery | MultiPoint Pacing |
Primary outcome
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
Time frame: up to 6-months
1 secondary outcome
echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Leclercq, MD, PhD principal investigator
University Hospital Rennes, Rennes, France
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT with MultiPoint Pacing and Hemodynamic measurements for CRT device programming in people with Heart Failure, run by Abbott Medical Devices at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Austria, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP (time frame: up to 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019; AzTrials last refreshed its copy on 2 Nov 2026.