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Completed

NCT Number: NCT00746135

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

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bad Rothenfelde, 49214, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device implantation

Device

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

Primary outcomes

  1. Improvement according to Packer's "Heart Failure Clinical Composite Respond"

    Time frame: 12 months post implant

Secondary outcomes

  1. Intraoperative Increase in Left Ventricular dp/dt

    Time frame: At Implant

  2. Cardiopulmonary Capacity(Spiroergometry)

    Time frame: 12 months

  3. Change in B-type natriuretic Peptide (BNP)-Concentration

    Time frame: 12 months

  4. 6 min walk test

    Time frame: 12 months

  5. QoL assessment("Minnesota Living with Heart Failure = MLHF)

    Time frame: 12 months

  6. 12 channel ECG

    Time frame: 12 months

  7. 2D-echo optimized EF

    Time frame: 12 months

  8. Complications and morbidity

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.

Acronym: TRI-V

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Sep 3, 2008
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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