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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Device Implantation
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure (NYHA class III and IV), Ventricular Dyssynchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

Conventional Biventricular Stimulation: RV Apex and LV Lead Tip

Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V".

Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2008
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00746135
Brief Title
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
Acronym
TRI-V
Official Title
TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure (NYHA class III and IV), Ventricular Dyssynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Conventional Biventricular Stimulation: RV Apex and LV Lead Tip
Arm Title
B
Arm Type
Active Comparator
Arm Description
Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V".
Arm Title
C
Arm Type
Active Comparator
Arm Description
Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His
Intervention Type
Device
Intervention Name(s)
Device Implantation
Other Intervention Name(s)
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
Intervention Description
RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
Primary Outcome Measure Information:
Title
Improvement according to Packer's "Heart Failure Clinical Composite Respond"
Time Frame
12 months post implant
Secondary Outcome Measure Information:
Title
Intraoperative Increase in Left Ventricular dp/dt
Time Frame
At Implant
Title
Cardiopulmonary Capacity(Spiroergometry)
Time Frame
12 months
Title
Change in B-type natriuretic Peptide (BNP)-Concentration
Time Frame
12 months
Title
6 min walk test
Time Frame
12 months
Title
QoL assessment("Minnesota Living with Heart Failure = MLHF)
Time Frame
12 months
Title
12 channel ECG
Time Frame
12 months
Title
2D-echo optimized EF
Time Frame
12 months
Title
Complications and morbidity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kranig, MD
Organizational Affiliation
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
City
Bad Rothenfelde
ZIP/Postal Code
49214
Country
Germany

12. IPD Sharing Statement

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

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