MPP Programming Study

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856725
• Other study ID #: CRD_684
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: February 2015

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Hemodynamic measurements for CRT device programming

Device:
• CRT device implant with MultiPoint Pacing

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital, GVM Care & Research	Cotignola	RA

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	end-systolic volume		6 months