Heart FailureNCT00187265
Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients
A study testing Cardiac Resynchronization Therapy in people with Heart Failure and Ventricular Dyssynchrony, run by Abbott Medical Devices at 1 site in France.
Trial summary
The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Dyssynchrony
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Apr 2003to Oct 2005
- 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
- NYHA class III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure for 1 month.
- The medical treatment must include a 40 mg/day minimum dose of furosemide (or equivalent);
- Permanent atrial fibrillation (AF);
- Left ventricular ejection fraction (LVEF) ≤ 35%;
- Indication for a pacemaker implantation for a permanent and symptomatic bradycardia, or already implanted pacemaker under the condition that leads positioning corresponds to the criteria described in the protocol;
- Aortic pre-ejection delay at least equal to 140 ms.
Who cannot join
- Indication for a cardiac defibrillator;
- Having presented a myocardial infarct within the previous 3 months;
- Having undergone cardiac surgery or coronary revascularization procedure within the previous 3 months, or being scheduled for such procedures;
- Presenting chronic pulmonary insufficiency;
- Patients whose congestive heart failure requires the use of an intravenous inotropic support;
- Presenting a dysthyreosis;
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- Having a life expectancy of less than one year, for other reasons than the congestive heart failure;
- Unable to be followed-up in the scope of the study for geographical reasons;
- Having refused to give their consent;
- Minors (age < 18 years) and pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triple Resynchronization in Paced Heart Failure Patients
The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).
- Conditions
- Heart Failure, Ventricular Dyssynchrony
- Being tested
- Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization TherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2003
- Study completionOct 2005
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
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Claude Daubert, Principal investigator, CHU Pontchaillou Rennes France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187265
- Sponsor's protocol ID
- CR03005HF
- Status last verified
- Feb 2019
- First submitted
- 13 Sep 2005
- Last updated
- 4 Feb 2019
- Results posted
- 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
- Triple Resynchronization in Paced Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00187265
- Acronym / sponsor ID
- CR03005HF
- Conditions
- Heart Failure, Ventricular Dyssynchrony
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Oct 2005
- First posted
- 16 Sep 2005 (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.
The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- NYHA class III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure for 1 month.
- The medical treatment must include a 40 mg/day minimum dose of furosemide (or equivalent);
- Permanent atrial fibrillation (AF);
- Left ventricular ejection fraction (LVEF) ≤ 35%;
- Indication for a pacemaker implantation for a permanent and symptomatic bradycardia, or already implanted pacemaker under the condition that leads positioning corresponds to the criteria described in the protocol;
Key exclusion criteria (10 listed)
- Indication for a cardiac defibrillator;
- Having presented a myocardial infarct within the previous 3 months;
- Having undergone cardiac surgery or coronary revascularization procedure within the previous 3 months, or being scheduled for such procedures;
- Presenting chronic pulmonary insufficiency;
- Patients whose congestive heart failure requires the use of an intravenous inotropic support;
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 |
|---|---|---|
| Cardiac Resynchronization Therapy | Device | – |
Primary outcome
Z-ratio
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.
Jean-Claude Daubert principal investigator
CHU Pontchaillou Rennes France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy in people with Heart Failure and Ventricular Dyssynchrony, run by Abbott Medical Devices at 1 site in France.
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 6 inclusion and 10 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 France. 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?
Z-ratio. 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.