AzTrials
AzTrials

Heart FailurePhase 3MPP IDENCT01786993

MultiPoint Pacing IDE Study

A Phase 3 study testing MultiPoint Pacing and Traditional Biventricular Pacing in people with Heart Failure, run by Abbott Medical Devices at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. 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?
MultiPoint Pacing and Traditional Biventricular Pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
506 participants
Where
49 sitesUnited States
Study dates
Apr 2013to Jun 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Cardiology Center of Amarillo, L.L.P

    Amarillo, Texas, 79106

  • St. Joseph's Hospital

    Atlanta, Georgia, 30342

  • Austin Heart

    Austin, Texas, 78756

  • Bay Area Cardiology Associates PA

    Brandon, Florida, 33511

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Lahey Clinic Medical Center

    Burlington, Massachusetts, 01805

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Novant Health Heart and Vascular Research Institute

    Charlotte, North Carolina, 28204

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio Health Research Institute

    Columbus, Ohio, 43124

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Glendale Memorial Hospital and Medical Center

    Glendale, California, 91206

  • Heart Center Research, LLC.

    Huntsville, Alabama, 35801

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Watson Clinic Center

    Lakeland, Florida, 33805

  • Colorado Heart & Vascular, P.C.

    Lakewood, Colorado, 80228

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Thoracic Cardio Healthcare Foundation

    Lansing, Michigan, 48910

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Banner Heart Hospital

    Mesa, Arizona, 85027

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53215

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • St. Thomas Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt Heart and Vascular Institute

    Nashville, Tennessee, 37232

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021

  • Christiana Hospital

    Newark, Delaware, 19718

  • Premier Cardiology, Inc

    Newport Beach, California, 92663

  • Cardiology Associates of Fairfield County, PC

    Norwalk, Connecticut, 06851

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • HeartCare Midwest

    Peoria, Illinois, 61614

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Regional Cardiology Associates

    Sacramento, California, 95819

  • Sutter Memorial Hospital

    Sacramento, California, 95819

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Cardiovascular Associates, LTD

    Virginia Beach, Virginia, 23454

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Wake Forest University Medical Center Clinical Sciences

    Winston-Salem, North Carolina, 27157

  • WellSpan Health

    York, Pennsylvania, 17403

Other trials in United States

About this study

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.

Read the detailed description

All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is programmed using any one of the 10 available pacing vectors. The paced/sensed atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up visit.

At the 3-month visit, responder status between Enrollment and 3 months will be assessed using the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened" or "Unchanged" using the definitions outlined in the CCS will be considered as Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g., Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with "equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm or MPP arm.

At the 9-month visit, responder status will be evaluated once again using the CCS and compared to the status at 3 months.

Conditions
Heart Failure
Being tested
MultiPoint Pacing, Traditional Biventricular Pacing
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MultiPoint PacingDevice

    Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.

  • Traditional Biventricular PacingDevice

    Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.

Study groups in NCT01786993
Study groupRoleWhat they receive
Multi-point pacing armExperimentalMultiPoint Pacing
Receives: Device: MultiPoint Pacing
Biventricular armActive comparatorTraditional Biventricular Pacing
Receives: Device: Traditional Biventricular Pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion

    A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.

    Measured: Implant to 9 months

  2. Percentage of Non-responders With MPP Compared to Biventricular Pacing

    The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below:

    • Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation
    • Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation.
    • Unchanged - patient was neither improved nor worsened

    For patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders.

    Measured: 3 months to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2015
  4. Study completionJun 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01786993
Sponsor's protocol ID
60029161/D
Acronym
MPP IDE
Status last verified
Jan 2019
First submitted
6 Feb 2013
Last updated
4 Feb 2019
Data monitoring committee
No
Individual data sharing
Yes: The study results will be presented at HRS Late-Breaking Clincial Trials Session in May, 2016

Publications

  • Varma N, Baker J 2nd, Tomassoni G, Love CJ, Martin D, Sheppard R, Niazi I, Cranke G, Lee K, Corbisiero R. Left Ventricular Enlargement, Cardiac Resynchronization Therapy Efficacy, and Impact of MultiPoint Pacing. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008680. doi: 10.1161/CIRCEP.120.008680. Epub 2020 Oct 7.

    PubMed 33028082

  • Niazi I, Baker J 2nd, Corbisiero R, Love C, Martin D, Sheppard R, Worley SJ, Varma N, Lee K, Tomassoni G; MPP Investigators. Safety and Efficacy of Multipoint Pacing in Cardiac Resynchronization Therapy: The MultiPoint Pacing Trial. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1510-1518. doi: 10.1016/j.jacep.2017.06.022. Epub 2017 Sep 27.

    PubMed 29759832

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MultiPoint Pacing and Traditional Biventricular Pacing in people with Heart Failure, run by Abbott Medical Devices at 49 sites in United States.

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 11 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 49 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion (time frame: Implant to 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01786993, which also lists 2 linked publications.

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 uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
MultiPoint Pacing IDE Study (NCT01786993) | AzTrials