Heart FailureNCT01367691
Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders
A study testing CRT reprogramming (Medtronic CRT) in people with Heart Failure, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients with CRT. Goals are to demonstrate that differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences in myocardial activation differences in LV-RV pacing delays cause differences in LV/RV hemodynamics… 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 reprogramming (Medtronic CRT)
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Dec 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
- presence of CRT device
- CRT non responder
Who cannot join
- pregnancy
- end-stage renal failure
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital, University of Bonn
Bonn, North Rhine-Westphalia, 53105
About this study
Official title: Cardiac MR (CMR) in Cardiac Resynchronization Therapy (CRT) Non-responders: Therapy Optimization by Means of Tissue Characterization, Hemodynamic Analysis and Analysis of Myocardial Activation
Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients with CRT.
Goals are to demonstrate that
- differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences in myocardial activation
- differences in LV-RV pacing delays cause differences in LV/RV hemodynamics and to use these data to optimize CRT.
Read the detailed description
CMR will be performed in patients under CRT who are currently not responding to CRT. Different LV-RV delays will be programmed during CMR and LV function and different dyssynchrony parameters will be assessed. Results will be used to determine the optimal LV-RV delay, and CRT-devices will be reprogrammed accordingly. Improvement in NYHA-class/conversion to therapy responder will be determined clinically after 3 months.
- Conditions
- Heart Failure
- Being tested
- CRT reprogramming (Medtronic CRT)
- Keywords
- CRT, heart failure, CMR, safety
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT reprogramming (Medtronic CRT)Device
Also called Medtronic CRT devices by Medtronic are eligable to be included in this study.
CRT devices will be reprogrammed according to CMR analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in NYHA-class
Measured: 6 months
Secondary outcomes (1)
safety of CMR in CRT-patients
pacing capture threshold, sensing and lead impedances will be monitored for significant and/or clinically relevant changes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2013
- Study completionDec 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claas P. Naehle, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367691
- Sponsor's protocol ID
- 206/10
- Status last verified
- Jan 2014
- First submitted
- 1 Jun 2011
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MR (CMR) in Cardiac Resynchronization Therapy (CRT) Non-responders: Therapy Optimization by Means of Tissue Characterization, Hemodynamic Analysis and Analysis of Myocardial Activation
- ClinicalTrials.gov ID
- NCT01367691
- Acronym / sponsor ID
- 206/10
- Conditions
- Heart Failure
- Keywords
- CRT, heart failure, CMR, safety
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jun 2011 (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.
Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients with CRT.
Goals are to demonstrate that
- differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences in myocardial activation
- differences in LV-RV pacing delays cause differences in LV/RV hemodynamics and to use these data to optimize CRT.
Detailed description
CMR will be performed in patients under CRT who are currently not responding to CRT. Different LV-RV delays will be programmed during CMR and LV function and different dyssynchrony parameters will be assessed. Results will be used to determine the optimal LV-RV delay, and CRT-devices will be reprogrammed accordingly. Improvement in NYHA-class/conversion to therapy responder will be determined clinically after 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of CRT device
- CRT non responder
Key exclusion criteria (2 listed)
- pregnancy
- end-stage renal failure
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 |
|---|---|---|
| CRT reprogramming (Medtronic CRT)Also: Medtronic CRT devices by Medtronic are eligable to be included in this study.CRT devices will be reprogrammed according to CMR analysis | Device | – |
Primary outcome
improvement in NYHA-class
Time frame: 6 months
1 secondary outcome
safety of CMR in CRT-patients
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
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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 reprogramming (Medtronic CRT) in people with Heart Failure, run by University Hospital, Bonn 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Feb 2014. 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 was stopped early. Results are not available in the source record.
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 in NYHA-class (time frame: 6 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 Feb 2014.