Heart FailurePhase 4CRTICD Dual LVNCT01415024
Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication
A Phase 4 study testing second LV lead in CRT in people with Heart Failure and Left Bundle-Branch Block, run by Schuechtermann-Klinik at 1 site in Germany.
Trial summary
Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately 70%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Left Bundle-Branch Block
- What is being tested?
- second LV lead in CRT
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to May 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EF less than 35 percent
- CAD or dilatative Cardiomyopathy
- Sinus rhythm
- NYHA III or IV, stable recompensated
- QRS more than 120ms
- LBBB
- Patient signed Consent Form
- Age more than 18 and less than 80 y
Who cannot join
- permanent atrial Fibrillation
- permanent AV-Block II or III
- Tricuspidal- and or artificial aortic valve
- Indication for ACB or ACB less than 3 months ago
- myocardial infarction less than 3 months
- hypertrophic obstructive Cardiomyopathy; constrictive Pericarditis
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- heartfailure with iv catecholamine therapy
- Manifested, uncontrolled, Hypo- oder Hyperthyreosis
- Severe renal insufficiency with Creatinine more than 2,5 mg per dL
- patients, who did not sign the consent form
- General medical conditions, which restrict the patient compliance
- Participation in another study
- life expectancy less than 1 y
- Age less than 18 y or more than 80y
- Pregnant women or Women of childbearing age
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schuechtermann-Klinik
Bad Rothenfelde, Lower Saxony, 49214
Wolfgang Kranig, MD, +49-5424-6410, wkranig@schuechtermann-klinik.de
Rainer Grove, MD, +49-5424-6410, rgrove@schuechtermann-klinik.de
About this study
Official title: Resynchronization in Paced Heart Failure Patients With ICD Indication
Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately 70%. However, the physiological agitation of the left ventricle takes place over two pathways. Therefore single point stimulation might be insufficient for a dilated, insufficiently and asynchronously contracting left ventricle, resulting in either insufficient or no response to the therapy.
In the "CRT ICD Dual LV" study the patients receive a second LV lead in an anterior vein. When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If there is an increase in LV dp/dt, the patients will be stimulated with both leads permanently. If not they will be stimulated conventionally.
The patients participating in this study are monitored for 12 months after implantation.
- Conditions
- Heart Failure, Left Bundle-Branch Block
- Being tested
- second LV lead in CRT
- Keywords
- CRT, Dual LV, Triple Ventricle stimulation, two leftventricular leads, Av VV optimization, Lv dp/dt measurement
- 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.
second LV lead in CRTProcedure or surgery
second LV lead in CRT
What is being measured
The primary outcome is the main question the study is designed to answer.
LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing
Measured: Implantation with pressure measurement will take place in the first week
Secondary outcomes (1)
Leftventricular endsystolic volume
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schuechtermann-Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Wolfgang Kranig, MD, Principal investigator, Schuechtermann-Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415024
- Sponsor's protocol ID
- BO/01/2011
- Acronym
- CRTICD Dual LV
- Status last verified
- Aug 2011
- First submitted
- 28 Jul 2011
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resynchronization in Paced Heart Failure Patients With ICD Indication
- ClinicalTrials.gov ID
- NCT01415024
- Acronym / sponsor ID
- CRTICD Dual LV / BO/01/2011
- Conditions
- Heart Failure, Left Bundle-Branch Block
- Keywords
- CRT, Dual LV, Triple Ventricle stimulation, two leftventricular leads, Av VV optimization, Lv dp/dt measurement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Schuechtermann-KlinikUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 11 Aug 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.
Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately 70%. However, the physiological agitation of the left ventricle takes place over two pathways. Therefore single point stimulation might be insufficient for a dilated, insufficiently and asynchronously contracting left ventricle, resulting in either insufficient or no response to the therapy.
In the "CRT ICD Dual LV" study the patients receive a second LV lead in an anterior vein. When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If there is an increase in LV dp/dt, the patients will be stimulated with both leads permanently. If not they will be stimulated conventionally.
The patients participating in this study are monitored for 12 months after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- EF less than 35 percent
- CAD or dilatative Cardiomyopathy
- Sinus rhythm
- NYHA III or IV, stable recompensated
- QRS more than 120ms
Key exclusion criteria (15 listed)
- permanent atrial Fibrillation
- permanent AV-Block II or III
- Tricuspidal- and or artificial aortic valve
- Indication for ACB or ACB less than 3 months ago
- myocardial infarction less than 3 months
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 |
|---|---|---|
| second LV lead in CRTsecond LV lead in CRT | Procedure or surgery | – |
Primary outcome
LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing
Time frame: Implantation with pressure measurement will take place in the first week
1 secondary outcome
Leftventricular endsystolic volume
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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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.
Wolfgang Kranig, MD principal investigator
Schuechtermann-Klinik
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 second LV lead in CRT in people with Heart Failure and Left Bundle-Branch Block, run by Schuechtermann-Klinik 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 15 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: status not confirmed, as of the sponsor's last update on 11 Aug 2011. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Kranig, MD (+49-5424-6410, wkranig@schuechtermann-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV dp/dt pressure during dual LV CRT stimulation vs. conventional biventricular pacing (time frame: Implantation with pressure measurement will take place in the first week). 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 11 Aug 2011.