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
About this trial
This is an interventional diagnostic trial for Heart Failure,Congestive
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
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
NCT ID
NCT03187470
First Posted
April 10, 2017
Last Updated
March 17, 2023
Sponsor
Adnan Kastrati, MD
Collaborators
Biotronik SE & Co. KG
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
Learn more about this trial
Left Ventricular Dyssynchrony in Multipole Pacing
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