Heart FailureINTREPIDNCT00819117
Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique
A study testing Cardiac Resynchronization Therapy implant in people with Heart Failure, run by Abbott Medical Devices at 2 sites in Italy.
Trial summary
The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2007to Oct 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
- Have a stable pharmacological therapy.
Who cannot join
- Have a contra-indication to general anesthesia;
- Have a scheduled cardiac surgery;
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
- Have a life expectancy of less than 6 months;
- Are unable to provide informed consent;
- Are unable to comply with the follow-up schedule and tests;
- Are minor (age below 18 years);
- Are pregnant or are planning for pregnancy in the next 6 months.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ospedale Cisanello
Pisa, 56126
Azienda Sanitaria Osperaliera Ordine Mauriziano
Torino, 10128
About this study
Official title: INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique
The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.
Read the detailed description
This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy.
After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups:
- Control group: resynchronization via a transvenous left ventricular lead (TVN CRT);
- Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT).
All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads.
Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy implant
- Keywords
- Epicardial leads, 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 Therapy implantDevice
Device implant with appropriate leads
| Study group | Role | What they receive |
|---|---|---|
| Transvenous Lead (TVN CRT) | Active comparator | Control group: resynchronization via a transvenous left ventricular lead (TVN CRT) Receives: Device: Cardiac Resynchronization Therapy implant |
| Epicardial Lead (EPI CRT) | Experimental | Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT) Receives: Device: Cardiac Resynchronization Therapy implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups.
Measured: 6 months follow up after implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startNov 2007
- Primary completionOct 2009
- Study completionOct 2009
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maria Grazia Bongiorni, MD, Principal investigator, Ospedale Cisanello, Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819117
- Sponsor's protocol ID
- CR05033IT
- Acronym
- INTREPID
- Status last verified
- Feb 2019
- First submitted
- 7 Jan 2009
- 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
- INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique
- ClinicalTrials.gov ID
- NCT00819117
- Acronym / sponsor ID
- INTREPID / CR05033IT
- Conditions
- Heart Failure
- Keywords
- Epicardial leads, Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Jan 2009 (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 demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.
Detailed description
This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy.
After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups:
- Control group: resynchronization via a transvenous left ventricular lead (TVN CRT);
- Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT).
All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads.
Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvenous Lead (TVN CRT) | Active comparator | Device: Cardiac Resynchronization Therapy implantControl group: resynchronization via a transvenous left ventricular lead (TVN CRT) |
| Epicardial Lead (EPI CRT) | Experimental | Device: Cardiac Resynchronization Therapy implantTreatment group: resynchronization via an epicardial left ventricular lead (EPI CRT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
- Have a stable pharmacological therapy.
Key exclusion criteria (8 listed)
- Have a contra-indication to general anesthesia;
- Have a scheduled cardiac surgery;
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
- Have a life expectancy of less than 6 months;
- Are unable to provide informed consent;
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 implantDevice implant with appropriate leads | Device | Epicardial Lead (EPI CRT), Transvenous Lead (TVN CRT) |
Primary outcome
The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups.
Time frame: 6 months follow up after implant
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.
Maria Grazia Bongiorni, MD principal investigator
Ospedale Cisanello, Pisa, Italy
2 sites 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 implant in people with Heart Failure, run by Abbott Medical Devices at 2 sites in Italy.
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 2 inclusion and 8 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 2 sites in Italy. 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?
The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups. (time frame: 6 months follow up after 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.