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

Primary Purpose

Heart Failure, Left Bundle-Branch Block

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
second LV lead in CRT
Sponsored by
Schuechtermann-Klinik
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring CRT, Dual LV, Triple Ventricle stimulation, two leftventricular leads, Av VV optimization, Lv dp/dt measurement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schuechtermann-KlinikRecruiting

Outcomes

Primary Outcome Measures

LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing

Secondary Outcome Measures

Leftventricular endsystolic volume

Full Information

First Posted
July 28, 2011
Last Updated
August 10, 2011
Sponsor
Schuechtermann-Klinik
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01415024
Brief Title
Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication
Acronym
CRTICD Dual LV
Official Title
Resynchronization in Paced Heart Failure Patients With ICD Indication
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Schuechtermann-Klinik
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Left Bundle-Branch Block
Keywords
CRT, Dual LV, Triple Ventricle stimulation, two leftventricular leads, Av VV optimization, Lv dp/dt measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
second LV lead in CRT
Intervention Description
second LV lead in CRT
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Leftventricular endsystolic volume
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang Kranig, MD
Phone
+49-5424-6410
Email
wkranig@schuechtermann-klinik.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rainer Grove, MD
Phone
+49-5424-6410
Email
rgrove@schuechtermann-klinik.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kranig, MD
Organizational Affiliation
Schuechtermann-Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schuechtermann-Klinik
City
Bad Rothenfelde
State/Province
Niedersachsen
ZIP/Postal Code
49214
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kranig, MD
Phone
+49-5424-6410
Email
wkranig@schuechtermann-klinik.de
First Name & Middle Initial & Last Name & Degree
Rainer Grove, MD
Phone
+49-5424-6410
Email
rgrove@schuechtermann-klinik.de

12. IPD Sharing Statement

Learn more about this trial

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

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