Heart FailureTRI-VNCT00746135
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
A study testing Device Implantation in people with Heart Failure, run by Abbott Medical Devices at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Device Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
Bad Rothenfelde, 49214
About this study
Official title: 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).
- Conditions
- Heart Failure
- Being tested
- Device Implantation
- Keywords
- Heart failure (NYHA class III and IV), Ventricular Dyssynchrony
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device ImplantationDevice
Also called 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
RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Conventional Biventricular Stimulation: RV Apex and LV Lead Tip Receives: Device: Device Implantation |
| B | Active comparator | Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V". Receives: Device: Device Implantation |
| C | Active comparator | Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His Receives: Device: Device Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement according to Packer's "Heart Failure Clinical Composite Respond"
Measured: 12 months post implant
Secondary outcomes (8)
Intraoperative Increase in Left Ventricular dp/dt
Measured: At Implant
Cardiopulmonary Capacity(Spiroergometry)
Measured: 12 months
Change in B-type natriuretic Peptide (BNP)-Concentration
Measured: 12 months
6 min walk test
Measured: 12 months
QoL assessment("Minnesota Living with Heart Failure = MLHF)
Measured: 12 months
12 channel ECG
Measured: 12 months
2D-echo optimized EF
Measured: 12 months
Complications and morbidity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kranig, MD, Principal investigator, Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746135
- Sponsor's protocol ID
- H37
- Acronym
- TRI-V
- Status last verified
- Jan 2019
- First submitted
- 20 Aug 2008
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRI-V Resynchronization in Paced Heart Failure Patients With ICD Indication.
- ClinicalTrials.gov ID
- NCT00746135
- Acronym / sponsor ID
- TRI-V / H37
- Conditions
- Heart Failure
- Keywords
- Heart failure (NYHA class III and IV), Ventricular Dyssynchrony
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Device ImplantationConventional Biventricular Stimulation: RV Apex and LV Lead Tip |
| B | Active comparator | Device: Device ImplantationAnodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V". |
| C | Active comparator | Device: Device ImplantationAnodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device ImplantationAlso: 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 MedicalRV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation | Device | A, B, C |
Primary outcome
Improvement according to Packer's "Heart Failure Clinical Composite Respond"
Time frame: 12 months post implant
8 secondary outcomes
Intraoperative Increase in Left Ventricular dp/dt
Time frame: At Implant
Cardiopulmonary Capacity(Spiroergometry)
Time frame: 12 months
Change in B-type natriuretic Peptide (BNP)-Concentration
Time frame: 12 months
6 min walk test
Time frame: 12 months
QoL assessment("Minnesota Living with Heart Failure = MLHF)
Time frame: 12 months
12 channel ECG
Time frame: 12 months
2D-echo optimized EF
Time frame: 12 months
Complications and morbidity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Kranig, MD principal investigator
Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device Implantation in people with Heart Failure, run by Abbott Medical Devices at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement according to Packer's "Heart Failure Clinical Composite Respond" (time frame: 12 months post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.