MultiPoint Pacing Mapping Study

NCT ID: NCT02547207

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Leclercq, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Rennes, Rennes, France

Locations

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CHU Pontchaillou

Rennes, , France

Site Status

Kerckhoff-Klinik GmbH

Bad Nauheim, , Germany

Site Status

Herzzentrum Dresden Universitätsklinik

Dresden, , Germany

Site Status

St. Thomas Hospital

London, , United Kingdom

Site Status

Countries

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France Germany United Kingdom

Other Identifiers

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CR-13-004-EU-HF

Identifier Type: -

Identifier Source: org_study_id

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