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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014