ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 398 for:    Recruiting, Not yet recruiting, Available Studies | "Heart Valve Diseases"

Valvular Heart Disease Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03488732
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.

Condition or disease Intervention/treatment
Valvular Heart Disease Device: Transcatheter valvular repair or replacement

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Valvular Heart Disease Registry - Observational Study of Percutaneous Valvular Interventions
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2030

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients undergonig transcatheter valvular interventions Device: Transcatheter valvular repair or replacement
Transcatheter valvular repair (predominantly MitraClip for mitral regurgitation) or replacement (predominantly transcatheter aortic valve implantation for aortic stenosis)




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 10 years ]
  2. NYHA status [ Time Frame: 10 years ]
  3. Grade of mitral regurgitation [ Time Frame: 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients undergoing transcatheter valvular interventions
Criteria

Inclusion Criteria:

- Severe valvular defect planned for valvular intervention

Exclusion Criteria:

- No informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488732


Locations
Germany
Klinik für Innere Medizin I Recruiting
München, Germany
Contact: Jakob Ledwoch, Dr    +4941402350    jakob.ledwoch@mri.tum.de   
Sponsors and Collaborators
Technische Universität München

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT03488732     History of Changes
Other Study ID Numbers: V1
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases