Heart FailureNCT01922544
EP-Catheter Guided CS-Lead Implantation
An observational study of Heart Failure and Reduced Left Ventricular Ejection Fraction, run by University of Cologne at 1 site in Germany.
Trial summary
In patients undergoing CRT device implantation a lead positioning in the coronary sinus is required. Even this part of the surgical procedure is challenging. In this study we compared retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Reduced Left Ventricular Ejection Fraction, Left Bundle Branch Block
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Aug 2013
- Phase
- Observational
- 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
Study population: Patients with symptomatic heart failure and reduced left ventricular ejection fraction. Asynchronic contraction of left and right ventricle was reflected by QRS duration > 120 ms in left precordial leads.
Who may be able to join
- CRT implantation due to heart failure
- full documented data
Who cannot join
- previous pacemaker/ICD/CRT implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Versus EP-Catheter Guided Implantation of Coronary Sinus Lead in Patients Undergoing Cardiac Resynchronization Therapy
In patients undergoing CRT device implantation a lead positioning in the coronary sinus is required. Even this part of the surgical procedure is challenging. In this study we compared retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided.
- Keywords
- heart failure, cardiac resynchronization therapy, coronary sinus lead
- Medical subject headings
- Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | In this group CS lead was implanted in a conventional manner. | |
| EP-catheter group | In this group coronary sinus was canulated using a steerable electrophysiology catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Fluoroscopy Time
During CRT device implantation fluoroscopy is used and the total fluoroscopy time is counted.
Measured: During implantation
Contrast medium account
contrast medium is used and counted during crt device implantation.
Measured: During surgical procedure
Secondary outcomes (1)
Successful implantation
Successful crt implantation was defined as effective positioning of RV and CS lead +/- right atrial lead.
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionAug 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fikret Er, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922544
- Sponsor's protocol ID
- CRT1
- Status last verified
- Aug 2013
- First submitted
- 11 Aug 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus EP-Catheter Guided Implantation of Coronary Sinus Lead in Patients Undergoing Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01922544
- Acronym / sponsor ID
- CRT1
- Keywords
- heart failure, cardiac resynchronization therapy, coronary sinus lead
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Aug 2013 (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.
In patients undergoing CRT device implantation a lead positioning in the coronary sinus is required. Even this part of the surgical procedure is challenging. In this study we compared retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | – | –In this group CS lead was implanted in a conventional manner. |
| EP-catheter group | – | –In this group coronary sinus was canulated using a steerable electrophysiology catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic heart failure and reduced left ventricular ejection fraction. Asynchronic contraction of left and right ventricle was reflected by QRS duration > 120 ms in left precordial leads.
Key inclusion criteria (2 listed)
- CRT implantation due to heart failure
- full documented data
Key exclusion criteria (1 listed)
- previous pacemaker/ICD/CRT implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Fluoroscopy Time
Time frame: During implantation
During CRT device implantation fluoroscopy is used and the total fluoroscopy time is counted.
Contrast medium account
Time frame: During surgical procedure
contrast medium is used and counted during crt device implantation.
1 secondary outcome
Successful implantation
Time frame: During surgical procedure
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 14 Aug 2013.
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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?
An observational study of Heart Failure and Reduced Left Ventricular Ejection Fraction, run by University of Cologne 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 1 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 14 Aug 2013. 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?
Total Fluoroscopy Time (time frame: During implantation). The study lists 2 primary outcomes in all. 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 14 Aug 2013.