Heart FailureNCT00822146
Cardiac Resynchronization Therapy (CRT) Efficacy Study
A study testing CRT in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
Trial summary
The aim of this research study is the invasive evaluation of CR therapy efficacy in patients treated with an InSync Sentry device using an external monitoring device to obtain important cardiac parameters. 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?
- CRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Mar 2013
- 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 indicated for InSync Sentry CRT device implant
- The patient must be willing and capable of following the study protocol
- EF ≤ 40%
- Systolic pulmonary artery pressure derived by echocardiography > 40
- Patients with their device functioning in a bi-ventricular mode, with defibrillation detection and therapy enabled
- Marked released transvenous RVCoil lead
Who cannot join
- Patients with chronic AF
- Patients with unipolar atrial or unipolar right ventricular leads
- Patients needing a Lower Rate faster than 110 beats per minute
- Patients with an implanted Medtronic Sentry in whom missing one day's fluid-measurement value is undesirable
- Patients who cannot tolerate turning off Rate Response during the study
- Patients with acute ischemia
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- Patients whose InSync Sentry battery is at ERI or EOL status
- Patients with "RAMware" downloaded from other studies
- Patients with medical conditions that would limit study participation
- Patients who are pregnant
- Patients enrolled in another study, which could influence the result of this study
- Patients on the heart transplantation list or patients with transplanted hearts
- Patients is not available for follow-up care
- Patients has not signed a consent form
- Patients with renal failure needing dialysis
- Patients whose compliance can expected to be poor
- Patients with a mechanical tricuspid valve
- Life expectation < 12 months
- Severe PAOD (peripheral arterial occlusive disease)
- Underage patients, pregnant or breast feeding women and female patients not using adequate contraception are excluded from participating in the study
- Since right after implantation study procedure will follow, patient has to sign the informed consent before the implantation. However the following criteria are device based and can therefore not checked at time of sign off.
- Therefore lead performance will be checked right after the implant and before the study specific procedure. If exclusion criteria are fulfilled patient exit the study and no study specific procedure will be done.
- Patients with non-intact or unstable leads, as indicated on the "Quick Look" screen of the Medtronic Model 2090 programmer by the presence of lead warnings such as the following:
- LV pacing lead impedance is > 2500 ohms
- LV pacing lead impedance is < 200 ohms
- A. pacing lead impedance is > 2500 ohms
- A. pacing lead impedance is < 200 ohms
- SVC defib lead impedance is > 200 ohms
- SVC defib lead impedance is < 20 ohms
- RV pacing lead impedance is > 2500 ohms
- RV pacing lead impedance is < 200 ohms
- Patients with atrial pacing thresholds lower than 1.0 volts at .03 ms
- Patients with right ventricular pacing thresholds lower than 1.0 volts at .03 ms
- Patients with left ventricular pacing thresholds lower than 1.0 volts at .03 ms
- Patients in whom a Lower Rate cannot be programmed to achieve consistent atrial pacing for the duration of download software installed
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research study is the invasive evaluation of CR therapy efficacy in patients treated with an InSync Sentry device using an external monitoring device to obtain important cardiac parameters.
- Conditions
- Heart Failure
- Being tested
- CRT
- Keywords
- CRT
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTDevice
classified
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
classified
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 posted14 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2011
- Study completionMar 2013
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822146
- Sponsor's protocol ID
- CEN_G_CA_11
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2009
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy (CRT) Efficacy Study
- ClinicalTrials.gov ID
- NCT00822146
- Acronym / sponsor ID
- CEN_G_CA_11
- Conditions
- Heart Failure
- Keywords
- CRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 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 aim of this research study is the invasive evaluation of CR therapy efficacy in patients treated with an InSync Sentry device using an external monitoring device to obtain important cardiac parameters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient indicated for InSync Sentry CRT device implant
- The patient must be willing and capable of following the study protocol
- EF ≤ 40%
- Systolic pulmonary artery pressure derived by echocardiography > 40
- Patients with their device functioning in a bi-ventricular mode, with defibrillation detection and therapy enabled
Key exclusion criteria (35 listed)
- Patients with chronic AF
- Patients with unipolar atrial or unipolar right ventricular leads
- Patients needing a Lower Rate faster than 110 beats per minute
- Patients with an implanted Medtronic Sentry in whom missing one day's fluid-measurement value is undesirable
- Patients who cannot tolerate turning off Rate Response during the study
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 |
|---|---|---|
| CRTclassified | Device | 1 |
Primary outcome
classified
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 3 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure 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 6 inclusion and 35 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 3 Jul 2025. 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?
classified (time frame: 12 months). 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 3 Jul 2025.