TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00746135

Purpose

It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac resynchronization therapy (CRT).

Condition	Intervention
Heart Failure	Device: Device Implantation

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Improvement according to Packer's "Heart Failure Clinical Composite Respond" [ Time Frame: 12 months post implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intraoperative Increase in Left Ventricular dp/dt [ Time Frame: At Implant ] [ Designated as safety issue: No ]
Cardiopulmonary Capacity(Spiroergometry) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in B-type natriuretic Peptide (BNP)-Concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
6 min walk test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
QoL assessment("Minnesota Living with Heart Failure = MLHF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
12 channel ECG [ Time Frame: 12 months ] [ Designated as safety issue: No ]
2D-echo optimized EF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complications and morbidity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Conventional Biventricular Stimulation: RV Apex and LV Lead Tip	Device: Device Implantation RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
B: Active Comparator Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V".	Device: Device Implantation RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
C: Active Comparator Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His	Device: Device Implantation RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure
LVEDD > 55 mm or > 30 mm/m² BSA
EF < 35%
Sinus rhythm and one of the following criteria:
QRS >= 120 ms and PQ >= 200ms
or
2nd / 3rd degree AV block
Written informed consent

Exclusion Criteria:

pacemaker indication (without ICD indication)
tricuspidal valve and/or aortic valve replacement
Indication for revascularization.
less than 3 month after heart surgery or myocardial infarction
hypertrophic obstructive cardiomyopathy
intravenous catecholamine treatment
uncorrected thyroid function
severe kidney disorder (creatinin >2,5mg%)
no written patient consent
insufficient patient compliance
participating in another study
life expectancy < 1 year due to other severe disease
age < 18 years
no contraception (young women) or pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746135

Contacts

Contact: Wolfgang Kranig, MD

+49-5424-641-1

wkranig@schuechtermann-klinik.de

Locations

Germany
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde	Recruiting
Bad Rothenfelde, Germany, 49214
Contact: Wolfgang Kranig +49-5424-641-1 wkranig@schuechtermann-klinik.de
Contact: Guido Lüdorff 05424-641-1
Principal Investigator: Wolfgang Kranig, MD
Sub-Investigator: Guido Lüdorff, MD
Sub-Investigator: Rainer Grove, MD

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:

Wolfgang Kranig, MD

Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde

More Information

Responsible Party:	St. Jude Medical GmbH ( Frank Birkenhauer )
Study ID Numbers:	H37
Study First Received:	August 20, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00746135
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:

Heart failure (NYHA class III and IV)
Ventricular Dyssynchrony

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009