MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02064751

Enrollment

Registered

2014-02-17

Start date

2014-03-31

Completion date

2016-06-30

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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).

Interventions

DEVICECRT with MultiPoint Pacing

PROCEDUREHemodynamic measurements for CRT device programming

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Austria, France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026