MultiPoint Pacing Mapping Study

The purpose of this study is to characterize left ventricular acute hemodynamic and electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint Pacing (MPP) settings, and assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing settings.

Study Overview

• Status: Terminated
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • CHU Pontchaillou
• Germany
  • Bad Nauheim, Germany, D-61231
    • Kerckhoff-Klinik GmbH
  • Dresden, Germany
    • Herzzentrum Dresden Universitätsklinik
• United Kingdom
  • London, United Kingdom
    • St. Thomas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients meeting specific eligibility criteria

Description

Inclusion Criteria:

• Be scheduled to undergo or have received within the past 30 days an implant of a SJM (St. Jude Medical) MPP CRT-D system with approved standard indication by ESC (European Society of Cardiology) / EHRA (European Heart Rhythm Association) 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
• Be in sinus rhythm

Exclusion Criteria:

• Complete AV (atrioventricular) block
• 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 7 months
• Have had a recent CVA (cerebrovascular accident) or TIA (transient ischemic attack) 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 plan to become pregnant over the next 7 months
• Have significant peripheral vascular disease
• Have LV thrombus
• Significant aortic valve disease or replacement
• Mitral valvular disease
• Contraindicated for Gadolinium contrast agent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Left ventricular (LV) dP/dt Max (maximum change in pressure over time) in mmHg/s during different pacing settings	up to 30 days post-implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Christophe Leclercq, MD, PhD, University Hospital Rennes, Rennes, France

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR-13-004-EU-HF