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

August 10, 2011 updated by: Schuechtermann-Klinik

Resynchronization in Paced Heart Failure Patients With ICD Indication

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Procedure: second LV lead in CRT

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- Niedersachsen
  - Bad Rothenfelde, Niedersachsen, Germany, 49214
    - Recruiting
    - Schuechtermann-klinik
    - Contact:
      
      Wolfgang Kranig, MD
      
      Phone Number: +49-5424-6410
      
      Email: wkranig@schuechtermann-klinik.de
    - Contact:
      
      Rainer Grove, MD
      
      Phone Number: +49-5424-6410
      
      Email: rgrove@schuechtermann-klinik.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Implantation with pressure measurement will take place in the first week

Secondary Outcome Measures

Outcome Measure	Time Frame
Leftventricular endsystolic volume Time Frame: 12 month	12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schuechtermann-Klinik

Collaborators

Medtronic

Investigators

Principal Investigator: Wolfgang Kranig, MD, Schuechtermann-klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (ESTIMATE)

August 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)