Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients
NCT ID: NCT04782908
Last Updated: 2021-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-03-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Transcatheter tricuspid valve edge-to-edge repair
Patients will undergo transcatheter tricuspid valve edge-to-edge repair (TTVR) and hemodynamic characteristics will be analysed on a multimodal approach using cardiac magnetic resonance imaging and pressure volume loop analysis before and after TTVR.
Transcatheter tricuspid valve edge-to-edge repair
Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.
Interventions
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Transcatheter tricuspid valve edge-to-edge repair
Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.
Eligibility Criteria
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Inclusion Criteria
* Signs and symptoms of left-sided heart failure.
* Left-ventricular ejection fraction ≥50%
* Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure \[PCWP\] or left-ventricular end-diastolic pressure ≥15 mmHg)
Exclusion Criteria
* Moderate aortic stenosis.
* Pregnancy
* Contraindication to perform cardiac magnetic resonance imaging.
* Conditions rendering patient unable to give informed consent to the study protocol.
18 Years
ALL
No
Sponsors
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Heart Center Leipzig - University Hospital
OTHER
Responsible Party
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Philipp Lurz
Professor, Managing Senior Physician
Locations
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Heart Centre at University Leipzig
Leipzig, Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HERACLES-HFpEF
Identifier Type: -
Identifier Source: org_study_id
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