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

NCT ID: NCT01415024

Last Updated: 2011-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Brief Summary

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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

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Conditions

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Heart Failure Left Bundle-Branch Block

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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second LV lead in CRT

second LV lead in CRT

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Schuechtermann-Klinik

OTHER

Sponsor Role lead

Responsible Party

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Schuechtermann- Klinik

Principal Investigators

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Wolfgang Kranig, MD

Role: PRINCIPAL_INVESTIGATOR

Schuechtermann-Klinik

Locations

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Schuechtermann-Klinik

Bad Rothenfelde, Lower Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Wolfgang Kranig, MD

Role: CONTACT

+49-5424-6410

Rainer Grove, MD

Role: CONTACT

+49-5424-6410

Facility Contacts

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Wolfgang Kranig, MD

Role: primary

+49-5424-6410

Rainer Grove, MD

Role: backup

+49-5424-6410

Other Identifiers

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BO/01/2011

Identifier Type: -

Identifier Source: org_study_id

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