Left Ventricular Dyssynchrony in Multipole Pacing

Heart Failure,Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187470
• Other study ID #: GER-EP-016
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: March 2023
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 31, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Intervention

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

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	Muenchen

Sponsors (2)

Lead Sponsor	Collaborator
Adnan Kastrati, MD	Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

References & 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 thera — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular dyssynchrony	Left ventricular dyssynchrony	15 minutes
Secondary	left ventricular ejection fraction	left ventricular ejection fraction	15 minutes