Left Ventricular Dyssynchrony in Multipole Pacing

March 17, 2023 updated by: Adnan Kastrati, MD

The Impact of Multipole Pacing (MPP) on Left Ventricular Dyssynchrony in Patients With Cardiac Resynchronization Therapy (CRT) - a Real-Time Three Dimensional Echocardiography Approach

Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator using a quadripolar left ventricular lead.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenchen, Germany, 80636
        • Deutsches Herzzentrum München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for the implantation of a defibrillator with cardiac resynchronisation therapy

Exclusion Criteria:

  • Cardiac surgery, acute coronary syndrome / myocardial infarction, percutaneous coronary intervention within the past 4 weeks
  • Indication for coronary artery revascularisation
  • Atrial fibrillation with insufficient rate control
  • ASA (American Society of Anesthesiologists) class V or cardiogenic shock
  • age <18 years, pregnancy, tutelage
  • inability to understand the patient consent for or study refusal
  • anticipated insufficient echocardiographic image quality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular dyssynchrony
Time Frame: 15 minutes
Left ventricular dyssynchrony
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricular ejection fraction
Time Frame: 15 minutes
left ventricular ejection fraction
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adnan Kastrati, MD

Collaborators

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Severin Weigand, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-EP-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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