Hypertrophic CardiomyopathyBIVENTNCT01081093
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
A study testing additional temporary pacewire in people with Hypertrophic Cardiomyopathy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure. A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- additional temporary pacewire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Aug 2014
- 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
- 18 years
- Hypertrophic Cardiomyopathy
- Aortic valve replacement
Who cannot join
- Atrial fibrillation
- Pericarditis
- postoperative low output
- Preoperative permanent pacemaker placement
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johann Wolfgang Goethe Universitätsklinikum
Frankfurt am Main, 60590
About this study
Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure.
A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure.
The investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- additional temporary pacewire
- Keywords
- Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction, Biventricular Pacemaker cardiac surgery aortic valve replacement
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional temporary pacewireProcedure or surgery
Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy
| Study group | Role | What they receive |
|---|---|---|
| Biventricular pacing | Experimental | Not described Receives: Procedure: additional temporary pacewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081093
- Sponsor's protocol ID
- Bivent001AR-AHK
- Acronym
- BIVENT
- Status last verified
- Aug 2014
- First submitted
- 4 Mar 2010
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT01081093
- Acronym / sponsor ID
- BIVENT / Bivent001AR-AHK
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction, Biventricular Pacemaker cardiac surgery aortic valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Mar 2010 (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.
Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure.
A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure.
The investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biventricular pacing | Experimental | Procedure: additional temporary pacewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years
- Hypertrophic Cardiomyopathy
- Aortic valve replacement
Key exclusion criteria (4 listed)
- Atrial fibrillation
- Pericarditis
- postoperative low output
- Preoperative permanent pacemaker placement
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 |
|---|---|---|
| additional temporary pacewirePlacement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy | Procedure or surgery | Biventricular pacing |
Primary outcome
Cardiac output
Time frame: intraoperative
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 6 Aug 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 additional temporary pacewire in people with Hypertrophic Cardiomyopathy, run by Johann Wolfgang Goethe University Hospital 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 3 inclusion and 4 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 6 Aug 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 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?
Cardiac output (time frame: intraoperative). 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 6 Aug 2014.