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
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
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
NCT ID
NCT00746135
First Posted
August 20, 2008
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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
Learn more about this trial
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
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