Heart FailurePhase 4CRT-NarrowNCT00821938
Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study
A Phase 4 study testing LV dp/dt pressure measurement in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
Trial summary
Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary… 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?
- LV dp/dt pressure measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Jul 2016
- Phase
- Phase 4
- 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
- EF < 35%
- CHD or dilate cardiomyopathy
- sinus rhythm
- NYHA III (or IV but stable recompenstated)
- QRS < 120 ms 2-3 of the following:
- LV-fillingtime < 40% of the cyclelength
- TDI septal-lateral (LV basal) > 60ms
- 2D-Strain-Score > 9 points
Who cannot join
- tricuspid or artificial valve
- AV block II or III or PQ time > 250ms
- revasculisation or condition after cardiac surgery < 3 months
- myocardial infarction or bypass OP < 3 months
- hytertrphic obstructive cardiomyopathy, constrictive pericarditis
- intravenous catecholamines because of HF
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- manifeste hyperthyreoses
- kidney failure (creatine >2,5 mg/dl)
- no written informed consent
- no compliance
- participation in another study
- life expectancy < 1 year
- patients < 18 years
- pragnancy or no safe contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire
Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters
- Conditions
- Heart Failure
- Being tested
- LV dp/dt pressure measurement
- Keywords
- Narrow QRS, 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.
LV dp/dt pressure measurementProcedure or surgery
Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly
LV dp/dt pressure measurementProcedure or surgery
Assessment of response to bi-ventricular pacing. Non-esponder-arm, will be treated with standard ICD-treatment
| Study group | Role | What they receive |
|---|---|---|
| CRT-ICD | Active comparator | Not described Receives: Procedure: LV dp/dt pressure measurement |
| DDD-ICD | Placebo comparator | Not described Receives: Procedure: LV dp/dt pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indexed left ventricular volume
Measured: 12 months
Secondary outcomes (1)
NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria
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 startNov 2008
- Primary completionJul 2012
- Study completionJul 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Guido Luedorff, MD, Principal investigator, Schuechtermann-Kliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821938
- Sponsor's protocol ID
- CEN_G_CA_10
- Acronym
- CRT-Narrow
- Status last verified
- Nov 2016
- 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
- CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire
- ClinicalTrials.gov ID
- NCT00821938
- Acronym / sponsor ID
- CRT-Narrow / CEN_G_CA_10
- Conditions
- Heart Failure
- Keywords
- Narrow QRS, CRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Nov 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2016 (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.
Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-ICD | Active comparator | Procedure: LV dp/dt pressure measurement |
| DDD-ICD | Placebo comparator | Procedure: LV dp/dt pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- EF < 35%
- CHD or dilate cardiomyopathy
- sinus rhythm
- NYHA III (or IV but stable recompenstated)
- QRS < 120 ms 2-3 of the following:
Key exclusion criteria (14 listed)
- tricuspid or artificial valve
- AV block II or III or PQ time > 250ms
- revasculisation or condition after cardiac surgery < 3 months
- myocardial infarction or bypass OP < 3 months
- hytertrphic obstructive cardiomyopathy, constrictive pericarditis
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 |
|---|---|---|
| LV dp/dt pressure measurementAssessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly | Procedure or surgery | CRT-ICD |
| LV dp/dt pressure measurementAssessment of response to bi-ventricular pacing. Non-esponder-arm, will be treated with standard ICD-treatment | Procedure or surgery | DDD-ICD |
Primary outcome
Indexed left ventricular volume
Time frame: 12 months
1 secondary outcome
NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria
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.
Guido Luedorff, MD principal investigator
Schuechtermann-Kliniken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LV dp/dt pressure measurement 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 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Indexed left ventricular volume (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.