NCT03187470

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

April 10, 2017

Last Update Submit

March 17, 2023

Conditions

Heart Failure，Congestive

Outcome Measures

Primary Outcomes (1)

  • Left ventricular dyssynchrony

    Left ventricular dyssynchrony

    15 minutes

Secondary Outcomes (1)

  • left ventricular ejection fraction

    15 minutes

Interventions

Different programming of a CRT defibrillatorDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

München, 80636, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30121181RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Severin Weigand, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Adnan Kastrati

Study Record Dates

First Submitted

April 10, 2017

First Posted

June 15, 2017

Study Start

March 1, 2017

Primary Completion

January 1, 2018

Study Completion

May 31, 2018

Last Updated

March 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)