MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

Heart Failure Clinical Trial

Official title:

Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064751
• Other study ID #: CRD_704
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: January 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 evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system

• Be in NYHA II or III functional class 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 persistent or 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 12 months

• Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment

• Have had intravenous inotropic support in the last 30 days

• Be scheduled or considered for heart transplantation over the next 12 months

• Be less than 18 years of age

• Be pregnant or plan to become pregnant over the next 12 months

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CRT with MultiPoint Pacing

Procedure:
• Hemodynamic measurements for CRT device programming

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
France	CHU Rennes	Rennes
Italy	Niguarda Hospital	Milan
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure changes in hemodynamics during BiV pacing and MPP		up to 6-months
Secondary	echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements	End systolic volume will be assessed at 6-month follow-up visit and compared to that of baseline.	6 months