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

January 31, 2019 updated by: Abbott Medical Devices

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Rothenfelde, Germany, 49214
        • Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement according to Packer's "Heart Failure Clinical Composite Respond"
Time Frame: 12 months post implant
12 months post implant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Wolfgang Kranig, MD, Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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