Left Ventricular Dyssynchrony in Multipole Pacing

Sponsor

Adnan Kastrati, MD (Other)

Overall Status

Completed

CT.gov ID

NCT03187470

Collaborator

Biotronik SE & Co. KG (Industry)

Enrollment

Location

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure，Congestive	Device: Different programming of a CRT defibrillator	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

May 31, 2018

Outcome Measures

Primary Outcome Measures

Left ventricular dyssynchrony [15 minutes]
Left ventricular dyssynchrony

Secondary Outcome Measures

left ventricular ejection fraction [15 minutes]
left ventricular ejection fraction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deutsches Herzzentrum München	Muenchen		Germany	80636

Sponsors and Collaborators

Adnan Kastrati, MD
Biotronik SE & Co. KG

Investigators

Principal Investigator: Severin Weigand, MD, Deutsches Herzzentrum Muenchen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adnan Kastrati, MD, Prof. Dr. Adnan Kastrati, Deutsches Herzzentrum Muenchen

ClinicalTrials.gov Identifier:

NCT03187470

Other Study ID Numbers:

GER-EP-016

First Posted:

Jun 15, 2017

Last Update Posted:

Aug 9, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Aug 9, 2018