Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement (BIVENT)
This study is currently recruiting participants.
Verified June 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01081093
First received: March 4, 2010
Last updated: June 4, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertrophic Cardiomyopathy |
Procedure: additional temporary pacewire |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial hypertrophic cardiomyopathy
supravalvular aortic stenosis
MedlinePlus related topics:
Cardiomyopathy
U.S. FDA Resources
Further study details as provided by Johann Wolfgang Goethe University Hospitals:
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Biventricular pacing |
Procedure: additional temporary pacewire
Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years
- Hypertrophic Cardiomyopathy
- Aortic valve replacement
Exclusion Criteria:
- Atrial fibrillation
- Pericarditis
- postoperative low output
- Preoperative permanent pacemaker placement
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081093
Contacts
| Contact: Arndt H Kiessling, MD | +49 (0) 69 / 6301 ext 0 |
Locations
| Germany | |
| Johann Wolfgang Goethe Universitätsklinikum | Recruiting |
| Frankfurt am Main, Germany, 60590 | |
| Contact: Arndt H Kiessling, MD +49 (0) 69 / 6301 ext 0 arndt.kiessling@kgu.de | |
| Johann Wolfgang Goethe Universitätsklinikum | Recruiting |
| Frankfurt am Main, Germany, 60590 | |
| Contact: Arndt H Kiessling, MD +49 69 6301 ext 87015 arndt.kiessling@kgu.de | |
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
More Information
No publications provided
| Responsible Party: | Arndt-H. Kiessling, PI, Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT01081093 History of Changes |
| Other Study ID Numbers: | Bivent001AR-AHK |
| Study First Received: | March 4, 2010 |
| Last Updated: | June 4, 2012 |
| Health Authority: | Germany: Ethikkommission Frankfurt am Main |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction Biventricular Pacemaker cardiac surgery aortic valve replacement |
Additional relevant MeSH terms:
|
Cardiomyopathy, Hypertrophic Hypertrophy Cardiomyopathies Heart Diseases Cardiovascular Diseases |
Aortic Stenosis, Subvalvular Aortic Valve Stenosis Heart Valve Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013