Left Ventricular Dyssynchrony in Multipole Pacing

NCT ID: NCT03187470

Last Updated: 2023-03-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-05-31

Brief Summary

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

Detailed Description

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

Conditions

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Heart Failure,Congestive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Different programming of a CRT defibrillator

Different programming of a CRT defibrillator using pacing modalities of a quadripolar left ventricular lead

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role collaborator

Adnan Kastrati, MD

OTHER

Sponsor Role lead

Responsible Party

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Adnan Kastrati, MD

Prof. Dr. Adnan Kastrati

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Severin Weigand, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum München

München, , Germany

Site Status

Countries

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Germany

References

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Weigand S, Karl M, Brkic A, Lennerz C, Grebmer C, Blazek P, Kornmayer M, Schaarschmidt C, Wesemann L, Reents T, Hessling G, Deisenhofer I, Kolb C. The impact of multipole pacing on left ventricular function in patients with cardiac resynchronization therapy - A real-time three-dimensional echocardiography approach. Int J Cardiol. 2018 Dec 1;272:238-243. doi: 10.1016/j.ijcard.2018.08.033. Epub 2018 Aug 15.

Reference Type RESULT
PMID: 30121181 (View on PubMed)

Other Identifiers

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GER-EP-016

Identifier Type: -

Identifier Source: org_study_id

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