Multi Point Pacing vs. Conventional STUDY PROTOCOL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2023-03-01

Brief Summary

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The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy

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Detailed Description

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Conditions

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Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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conventional CRT

Group Type PLACEBO_COMPARATOR

conventional CRT

Intervention Type DEVICE

Conventional CRT or biventricular pacing "resynchronizes" left ventricular contraction by pacing the right and left ventricles (LV) simultaneously

MPP CRT

Group Type EXPERIMENTAL

MPP CRT

Intervention Type DEVICE

CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously

Interventions

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conventional CRT

Conventional CRT or biventricular pacing "resynchronizes" left ventricular contraction by pacing the right and left ventricles (LV) simultaneously

Intervention Type DEVICE

MPP CRT

CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months

Exclusion Criteria

* \< 18 years and younger
* Pregnant or breastfeeding patients
* Non-LBBB patients (RBBB, intra-ventricular delay)
* Non-ambulatory NYHA class IV effort tolerance
* Myocardial infarction within 40 days before enrolment
* Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months
* Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery)
* Patients with life expectancy of less than 12 months due to other medical conditions
* Patients who are involved in another investigational study (device or medical)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No