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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746135
First Posted: September 3, 2008
Last Update Posted: October 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Intraoperative Increase in Left Ventricular dp/dt [ Time Frame: At Implant ]
  • Cardiopulmonary Capacity(Spiroergometry) [ Time Frame: 12 months ]
  • Change in B-type natriuretic Peptide (BNP)-Concentration [ Time Frame: 12 months ]
  • 6 min walk test [ Time Frame: 12 months ]
  • QoL assessment("Minnesota Living with Heart Failure = MLHF) [ Time Frame: 12 months ]
  • 12 channel ECG [ Time Frame: 12 months ]
  • 2D-echo optimized EF [ Time Frame: 12 months ]
  • Complications and morbidity [ Time Frame: 12 months ]

Enrollment: 40
Study Start Date: November 2007
Study Completion Date: December 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
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
Other Names:
  • CRT-D Devices:
  • Atlas™ II+ HF / V-367 /St. Jude Medical
  • Epic™ II+ HF / V-357 / St. Jude Medical
  • Promote™ / 3207-36 / 3213-36 / St. Jude Medical
  • Adapters:
  • VIS 16 / Dr. Osypka GmbH
Active Comparator: B
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
Other Names:
  • CRT-D Devices:
  • Atlas™ II+ HF / V-367 /St. Jude Medical
  • Epic™ II+ HF / V-357 / St. Jude Medical
  • Promote™ / 3207-36 / 3213-36 / St. Jude Medical
  • Adapters:
  • VIS 16 / Dr. Osypka GmbH
Active Comparator: C
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
Other Names:
  • CRT-D Devices:
  • Atlas™ II+ HF / V-367 /St. Jude Medical
  • Epic™ II+ HF / V-357 / St. Jude Medical
  • Promote™ / 3207-36 / 3213-36 / St. Jude Medical
  • Adapters:
  • VIS 16 / Dr. Osypka GmbH

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746135


Locations
Germany
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
Bad Rothenfelde, Germany, 49214
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
ClinicalTrials.gov Identifier: NCT00746135     History of Changes
Other Study ID Numbers: H37
First Submitted: August 20, 2008
First Posted: September 3, 2008
Last Update Posted: October 24, 2016
Last Verified: October 2016

Keywords provided by St. Jude Medical:
Heart failure (NYHA class III and IV)
Ventricular Dyssynchrony

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases