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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00746135
First received: August 20, 2008
Last updated: July 26, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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 ]

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

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

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00746135     History of Changes
Other Study ID Numbers: H37
Study First Received: August 20, 2008
Last Updated: July 26, 2013
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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014