Clinical trial NCT02322840: Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Official title: An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Valve Insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2014-12-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PILOT:

The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high risk mitral regurgitation patients.

EFS:

The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe, Symptomatic Mitral Regurgitation

Detailed description: PILOT:

The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high-risk patients with severe, symptomatic mitral regurgitation, who are deemed ineligible for standard surgery.

EFS:

The study is a multi-center, prospective, non-randomized, trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe, Symptomatic Mitral Regurgitation

Eligibility criteria: Key Inclusion Criteria:

* Severe mitral regurgitation (MR Grade 3-4+)
* Symptomatic mitral regurgitation (NYHA Class II-IV)
* Trans-apical access deemed feasible by the treating physician (PILOT only)
* Subjects anatomically suitable for the Intrepid TMVR delivery system including transfemoral and transseptal access (EFS only)
* Native mitral valve geometry and size compatible with the Twelve TMVR/Intrepid

Key Exclusion Criteria:

* Left ventricular ejection fraction (LVEF) \< 20 (PILOT) or \<25% (EFS)
* Evidence of intracardiac mass, thrombus, or vegetation
* Prior valve surgery or need for other valve surgery
* Prior stroke within 4 weeks (PILOT) or 90 days (EFS)
* Prior myocardial infarction within 6 months (PILOT) or 90 days (EFS)
* Need for coronary revascularization
* History of, or active, endocarditis
* Renal insufficiency (Creatinine \> 2.5 mg/dL)

Primary outcomes:
measure: Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Procedural Success (Number of patients with successful TMVR placement)
timeFrame: Through 5 years
measure: Reduction of MR (Number of patients with a reduction of MR Grade)
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Abrazo Arizon Heart Hospital
state: Arizona
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences University Hospital
state: Oregon
city: Wormleysburg
country: United States
facility: UPMC Pinnacle Harrisburg
state: Pennsylvania
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's
state: Wisconsin
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Lille
country: France
facility: Centre Hospitalier Universitaire
city: London
country: United Kingdom
facility: St. Thomas' Hospital
Study officials:
affiliation: Medtronic
name: Lynnett Stahl
role: STUDY_DIRECTOR
References:
citation: Zahr F, Song HK, Chadderdon SM, Gada H, Mumtaz M, Byrne T, Kirshner M, Bajwa T, Weiss E, Kodali S, George I, Heiser J, Merhi WM, Thaden JJ, Zhang A, Lim DS, Reardon MJ, Adams DH, Mack MJ, Leon MB. 30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. JACC Cardiovasc Interv. 2022 Jan 10;15(1):80-89. doi: 10.1016/j.jcin.2021.10.018. Epub 2021 Nov 6.
citation: Bapat V, Rajagopal V, Meduri C, Farivar RS, Walton A, Duffy SJ, Gooley R, Almeida A, Reardon MJ, Kleiman NS, Spargias K, Pattakos S, Ng MK, Wilson M, Adams DH, Leon M, Mack MJ, Chenoweth S, Sorajja P; Intrepid Global Pilot Study Investigators. Early Experience With New Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2018 Jan 2;71(1):12-21. doi: 10.1016/j.jacc.2017.10.061. Epub 2017 Nov 16.