TerminatedNot Applicable

MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

Stopped: The steering committee had decided to discontinue enrollment because the interim analysis showed a low probability that the study would meet the primary endpoint. The interim analysis did not demonstrate any safety concerns with activating MPP.

United States, Australia, Austria5,850 participantsStarted 2013-12

Plain-language summary

The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs) * Must be willing and able to comply with study requirements * Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form Exclusion Criteria: * Already had a CRT device implanted * Myocardial Infarction, unstable angina within 40 days prior the enrollment * Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following * Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment * Primary valvular disease * Atrial Fibrillation: * Persistent AF at the time of enrollment * Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant * History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment * Unable to comply with the follow up schedule * Less than 18 years of age * Pregnant or are planning to become pregnant during the duration of the investigation * Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months * Undergone a cardiac transplantation * Life expectancy \< 12 months * Currently participating in any other clinical investigation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Non-responder Patients Who Converted to Responders

Timeframe: Non-responder to responder conversion rate between randomization at 6 months and 12 months

Trial details

NCT IDNCT02006069

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-30

Results submitted2022-05-25

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