STS/ACC TVT Registry Mitral Module
TMVR
The Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapies Registry Mitral Module
1 other identifier
observational
4,000
1 country
1
Brief Summary
The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter mitral valve repair (TMVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of mitral valve disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 2, 2014
CompletedFirst Posted
Study publicly available on registry
September 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 18, 2024
April 1, 2024
17.1 years
September 2, 2014
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients with Adverse Events
30 days
Interventions
Eligibility Criteria
Transcatheter Mitral Valve Repair must be furnished in a hospital with the appropriate infrastructre that includes, but is not limited to on site heart valve surgery program cardiac catheterization lab or hybrid operating room with a fixed radiographic imaging system with flat panel fluoroscopy, offering quality imaging non-invasive imaging such as echocardiography, vascular ultrasound, computed tomography and magnetic resonance. Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures.
You may qualify if:
- All patients
You may not qualify if:
- Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen
- Active endocarditis of the mitral valve
- Rheumatic mitral valve disease
- Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American College of Cardiologylead
- The Society of Thoracic Surgeonscollaborator
Study Sites (1)
American College of Cardiology
Washington D.C., District of Columbia, 20037, United States
Related Publications (4)
Guerrero ME, Bapat VN, Mahoney P, Krishnaswamy A, Eleid MF, Eng MH, Yadav P, Coylewright M, Makkar R, Szerlip M, Nazif T, Kodali S, George I, Greenbaum A, Babaliaros V, Kapadia S, Rihal CS, Whisenant B, Thourani VH, McCabe JM. Contemporary 1-Year Outcomes of Mitral Valve-in-Ring With Balloon-Expandable Aortic Transcatheter Valves in the U.S. JACC Cardiovasc Interv. 2024 Apr 8;17(7):874-886. doi: 10.1016/j.jcin.2024.02.012.
PMID: 38599690DERIVEDMack M, Carroll JD, Thourani V, Vemulapalli S, Squiers J, Manandhar P, Deeb GM, Batchelor W, Herrmann HC, Cohen DJ, Hanzel G, Gleason T, Kirtane A, Desai N, Guibone K, Hardy K, Michaels J, DiMaio JM, Christensen B, Fitzgerald S, Krohn C, Brindis RG, Masoudi F, Bavaria J. Transcatheter Mitral Valve Therapy in the United States: A Report From the STS-ACC TVT Registry. J Am Coll Cardiol. 2021 Dec 7;78(23):2326-2353. doi: 10.1016/j.jacc.2021.07.058. Epub 2021 Oct 25.
PMID: 34711430DERIVEDMack M, Carroll JD, Thourani V, Vemulapalli S, Squiers J, Manandhar P, Deeb GM, Batchelor W, Herrmann HC, Cohen DJ, Hanzel G, Gleason T, Kirtane A, Desai N, Guibone K, Hardy K, Michaels J, DiMaio JM, Christensen B, Fitzgerald S, Krohn C, Brindis RG, Masoudi F, Bavaria J. Transcatheter Mitral Valve Therapy in the United States: A Report from the STS/ACC TVT Registry. Ann Thorac Surg. 2022 Jan;113(1):337-365. doi: 10.1016/j.athoracsur.2021.07.030. Epub 2021 Oct 25.
PMID: 34711394DERIVEDGuerrero M, Vemulapalli S, Xiang Q, Wang DD, Eleid M, Cabalka AK, Sandhu G, Salinger M, Russell H, Greenbaum A, Kodali S, George I, Dvir D, Whisenant B, Russo MJ, Pershad A, Fang K, Coylewright M, Shah P, Babaliaros V, Khan JM, Tommaso C, Saucedo J, Kar S, Makkar R, Mack M, Holmes D, Leon M, Bapat V, Thourani VH, Rihal C, O'Neill W, Feldman T. Thirty-Day Outcomes of Transcatheter Mitral Valve Replacement for Degenerated Mitral Bioprostheses (Valve-in-Valve), Failed Surgical Rings (Valve-in-Ring), and Native Valve With Severe Mitral Annular Calcification (Valve-in-Mitral Annular Calcification) in the United States: Data From the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. Circ Cardiovasc Interv. 2020 Mar;13(3):e008425. doi: 10.1161/CIRCINTERVENTIONS.119.008425. Epub 2020 Mar 6.
PMID: 32138529DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2014
First Posted
September 22, 2014
Study Start
November 1, 2013
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
April 18, 2024
Record last verified: 2024-04