- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01081093
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement (BIVENT)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Frankfurt am Main, Germany, 60590
- Johann Wolfgang Goethe Universitätsklinikum
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years
- Hypertrophic Cardiomyopathy
- Aortic valve replacement
Exclusion Criteria:
- Atrial fibrillation
- Pericarditis
- postoperative low output
- Preoperative permanent pacemaker placement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biventricular pacing
|
Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiac output
Time Frame: intraoperative
|
intraoperative
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bivent001AR-AHK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertrophic Cardiomyopathy
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French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
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University of Sao PauloCompletedNon-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyBrazil
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Montreal Heart InstituteCanadian Institutes of Health Research (CIHR)Enrolling by invitationCardiomyopathies | Hypertrophic Cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Familial Hypertrophic CardiomyopathyCanada
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Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
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Yonsei UniversityCompletedFamilial Hypertrophic CardiomyopathyKorea, Republic of
-
Hangzhou Valgen Medtech Co., LtdNot yet recruitingObstructive Hypertrophic CardiomyopathyChina
-
China National Center for Cardiovascular DiseasesNot yet recruitingObstructive Hypertrophic Cardiomyopathy
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Bristol-Myers SquibbNot yet recruitingObstructive Hypertrophic CardiomyopathyKorea, Republic of
-
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.RecruitingObstructive Hypertrophic CardiomyopathyChina
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Xiang WeiRecruitingNonobstructive Hypertrophic CardiomyopathyChina
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Epineuron Technologies Inc.RecruitingNerve InjuryCanada, United States
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Fundacion para la Investigacion Biomedica del Hospital...Completed
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Hadassah Medical OrganizationUnknown
-
The University of New South WalesCompleted
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University of WuerzburgCompleted
-
Skane University HospitalRecruitingJugular Vein Occlusion | Subclavian Vein StenosisSweden
-
University of California, San FranciscoRecruitingRight Ventricular Dysfunction | Pulmonary Artery HypertensionUnited States