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Left Ventricular Dyssynchrony in Multipole Pacing

Primary Purpose

Heart Failure，Congestive

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Different programming of a CRT defibrillator
Sponsored by
Adnan Kastrati, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure，Congestive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deutsches Herzzentrum München

Outcomes

Primary Outcome Measures

Left ventricular dyssynchrony
Left ventricular dyssynchrony

Secondary Outcome Measures

left ventricular ejection fraction
left ventricular ejection fraction

Full Information

First Posted
April 10, 2017
Last Updated
March 17, 2023
Sponsor
Adnan Kastrati, MD
Collaborators
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT03187470
Brief Title
Left Ventricular Dyssynchrony in Multipole Pacing
Official Title
The Impact of Multipole Pacing (MPP) on Left Ventricular Dyssynchrony in Patients With Cardiac Resynchronization Therapy (CRT) - a Real-Time Three Dimensional Echocardiography Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adnan Kastrati, MD
Collaborators
Biotronik SE & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure，Congestive

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Different programming of a CRT defibrillator
Intervention Description
Different programming of a CRT defibrillator using pacing modalities of a quadripolar left ventricular lead
Primary Outcome Measure Information:
Title
Left ventricular dyssynchrony
Description
Left ventricular dyssynchrony
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
left ventricular ejection fraction
Description
left ventricular ejection fraction
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Severin Weigand, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum München
City
Muenchen
ZIP/Postal Code
80636
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30121181
Citation
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.
Results Reference
result

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Left Ventricular Dyssynchrony in Multipole Pacing

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