MultiPoint Pacing Mapping Study

NCT02547207 | Terminated

• 1 other identifier: CR-13-004-EU-HF
• Study Type: observational
• Target: 7
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients meeting specific eligibility criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (4)

CHU Pontchaillou

Rennes, France

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, D-61231, Germany

Location

Herzzentrum Dresden Universitätsklinik

Dresden, Germany

Location

St. Thomas Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christophe Leclercq, MD, PhD

  University Hospital Rennes, Rennes, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: September 11, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

FR (1); DE (2); GB (1)