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

NCT01415024 | Unknown Phase 4

• 1 other identifier: BO/01/2011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Left Bundle-Branch Block

Keywords

CRT; Dual LV; Triple Ventricle stimulation; two leftventricular leads; Av VV optimization; Lv dp/dt measurement

Outcome Measures

Primary Outcomes (1)

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

  Implantation with pressure measurement will take place in the first week

Secondary Outcomes (1)

• Leftventricular endsystolic volume

  12 month

Interventions

second LV lead in CRT PROCEDURE

second LV lead in CRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schuechtermann-Klinik: lead
• Medtronic: collaborator

Study Sites (1)

Schuechtermann-Klinik

Bad Rothenfelde, Lower Saxony, 49214, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfgang Kranig, MD

  Schuechtermann-Klinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Kranig, MD

CONTACT

+49-5424-6410; wkranig@schuechtermann-klinik.de

Rainer Grove, MD

CONTACT

+49-5424-6410; rgrove@schuechtermann-klinik.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 11, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Last Updated: August 11, 2011

Record last verified: 2011-08

Locations

DE (1)