MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: CRT with MultiPoint Pacing; Procedure: Hemodynamic measurements for CRT device programming

• Registration Number: NCT02064751
• Lead Sponsor: Abbott Medical Devices

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-03
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MultiPoint Pacing	Hemodynamic measurements for CRT device programming	CRT with MultiPoint Pacing
MultiPoint Pacing	CRT with MultiPoint Pacing	CRT with MultiPoint Pacing

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP	up to 6-months

Secondary Outcome Measures

Name	Time	Method
echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements	6 months	End systolic volume will be assessed at 6-month follow-up visit and compared to that of baseline.

Trial Locations

Locations (4)

CHU Rennes; 🇫🇷 Rennes, France

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Niguarda Hospital; 🇮🇹 Milan, Italy