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OpenTrials
Completed

NCT Number: NCT01856725

MPP Programming Study

The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Cecilia Hospital, GVM Care & Research

Cotignola, RA, 48010, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system 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 high ventricular rate (>90 bpm) during persistent or permanent atrial fibrillation despite available treatment
  • Be in NYHA IV functional class
  • Have a recent myocardial infarction within 40 days prior to enrollment
  • Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
  • Have had a recent CVA or TIA within 3 months prior to enrollment
  • Have had intravenous inotropic support in the last 30 days
  • Be less than 18 years of age
  • Be pregnant or planning to become pregnant during the duration of the investigation.

Treatment and study plan

Hemodynamic measurements for CRT device programming

Procedure

CRT device implant with MultiPoint Pacing

Device

Primary outcomes

  1. end-systolic volume

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Evaluation of Programming Strategies for MultiPoint™ Pacing in Cardiac Resynchronization Therapy Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 17, 2013
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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