MultiPoint Pacing Mapping Study

Heart Failure Clinical Trial

Official title:

MultiPoint Pacing Mapping Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02547207
• Other study ID #: CR-13-004-EU-HF
• Status: Terminated
• Start date: December 2015
• Est. completion date: October 2018

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
France	CHU Pontchaillou	Rennes
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Herzzentrum Dresden Universitätsklinik	Dresden
United Kingdom	St. Thomas Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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