Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication (CRTICD Dual LV)

This study is currently recruiting participants.

Verified August 2011 by Schuechtermann-Klinik

Sponsor:

Collaborator:

Medtronic

Information provided by:

Schuechtermann-Klinik

ClinicalTrials.gov Identifier:

NCT01415024

First received: July 28, 2011

Last updated: August 10, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 28, 2011

Last Updated Date

August 10, 2011

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing [ Time Frame: Implantation with pressure measurement will take place in the first week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01415024 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Leftventricular endsystolic volume [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication

Official Title ^ICMJE

Resynchronization in Paced Heart Failure Patients With ICD Indication

Brief Summary

Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately 70%. However, the physiological agitation of the left ventricle takes place over two pathways. Therefore single point stimulation might be insufficient for a dilated, insufficiently and asynchronously contracting left ventricle, resulting in either insufficient or no response to the therapy.

In the "CRT ICD Dual LV" study the patients receive a second LV lead in an anterior vein. When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If there is an increase in LV dp/dt, the patients will be stimulated with both leads permanently. If not they will be stimulated conventionally.

The patients participating in this study are monitored for 12 months after implantation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure
Left Bundle-Branch Block

Intervention ^ICMJE

Procedure: second LV lead in CRT

second LV lead in CRT

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

EF less than 35 percent
CAD or dilatative Cardiomyopathy
Sinus rhythm
NYHA III or IV, stable recompensated
QRS more than 120ms
LBBB
Patient signed Consent Form
Age more than 18 and less than 80 y

Exclusion Criteria:

permanent atrial Fibrillation
permanent AV-Block II or III
Tricuspidal- and or artificial aortic valve
Indication for ACB or ACB less than 3 months ago
myocardial infarction less than 3 months
hypertrophic obstructive Cardiomyopathy; constrictive Pericarditis
heartfailure with iv catecholamine therapy
Manifested, uncontrolled, Hypo- oder Hyperthyreosis
Severe renal insufficiency with Creatinine more than 2,5 mg per dL
patients, who did not sign the consent form
General medical conditions, which restrict the patient compliance
Participation in another study
life expectancy less than 1 y
Age less than 18 y or more than 80y
Pregnant women or Women of childbearing age

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Wolfgang Kranig, MD	+49-5424-6410	wkranig@schuechtermann-klinik.de
Contact: Rainer Grove, MD	+49-5424-6410	rgrove@schuechtermann-klinik.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01415024

Other Study ID Numbers ^ICMJE

BO/01/2011

Has Data Monitoring Committee

Responsible Party

Dr. med. Wolfgang Kranig, Schuechtermann- Klinik

Study Sponsor ^ICMJE

Schuechtermann-Klinik

Collaborators ^ICMJE

Medtronic

Investigators ^ICMJE

Principal Investigator:

Wolfgang Kranig, MD

Schuechtermann-Klinik

Information Provided By

Schuechtermann-Klinik

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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