Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03539458
• Collaborator: (none)
• Enrollment: 11
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 71.7
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation; Mitral Insufficiency; Mitral Annular Calcification; Mitral Annulus Calcification; Cardiovascular Diseases; Valve Heart Disease; Heart Valve Diseases; Heart Valve Calcification; Mitral Valve Disease	Device: Tendyne Mitral Valve System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
• Actual Study Start Date: Oct 10, 2018
• Actual Primary Completion Date: Nov 29, 2019
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device Arm All subjects will undergo procedure with the Tendyne Mitral Valve System.	Device: Tendyne Mitral Valve System; Mitral valve replacement

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC) [30 days post implant]

   Definition of Device Success: All of the following must be present: Absence of procedural mortality or stroke; and Proper placement and positioning of the device, and Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of MAC present and the subject will likely benefit from transcatheter valve implantation

2. Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR

3. NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)

4. Age 18 years or older at time of consent

5. Not a member of a vulnerable population per the investigator's judgment

6. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions, including complying with study required testing and follow-up visits, and has provided written informed consent

Exclusion criteria:

1. Presence of Left Ventricle or Left Atrium thrombus

2. Chest condition that prevents transapical access

3. Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram

4. Left Ventricular End Diastolic Dimension (LVEDD) > 7.0 cm

5. Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy

6. Prior intervention with permanently implanted mitral device (e.g. MitraClip)

7. Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation

8. Any planned cardiac surgery or intervention that is 30 days prior and 30 days post that is not concomitant with the Tendyne procedure

9. Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG) implanted within three months of planned implant procedure

10. Myocardial Infarction (MI) within 30 days of the planned implant procedure

11. Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia) amenable to revascularization and thus requiring stenting or CABG

12. Cerebrovascular accident (CVA) within six months of planned implant procedure

13. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)

14. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices within 1 month prior to planned implant procedure

15. Severe tricuspid regurgitation or severe right ventricular dysfunction

16. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology

17. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated

18. History of endocarditis within 6 months of planned implant procedure

19. Active systemic infection requiring antibiotic therapy

20. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically

21. Subject unable or unwilling to take anticoagulation with warfarin for a minimum of 6 months following Tendyne valve implantation

22. Known hypersensitivity to nickel or titanium

23. Subject is undergoing hemodialysis due to chronic renal failure ( ≥ Stage 4 CKD)

24. Subject has pulmonary arterial hypertension (fixed PAS >70mmHg)

25. FEV1 < 50% of predicted or < 1L

26. Subject refuses blood transfusions

27. Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use

28. Pregnant, lactating, or planning pregnancy within next 12 months.

29. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint

30. Subjects with non-cardiac co-morbidities that are likely to result in a life expectancy of less than 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital	Atlanta	Georgia	United States	30322
2	Cardiovascular Research Institute of Kansas	Wichita	Kansas	United States	67226
3	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
4	West Virginia University	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Paul Sorajja, MD, Minneapolis Heart Institute - Abbott Northwestern Hospital
• Principal Investigator: Vinod Thourani, MD, Piedmont Heart Hospital
• Study Director: Kartik Sundareswaran, PhD, Abbott Structural Heart

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 25, 2018

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03539458
• Other Study ID Numbers: CS0005-P
• First Posted: May 29, 2018
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Mitral Valve Insufficiency; Heart Valve Diseases; Calcinosis

Study Results

Participant Flow

Recruitment Details	The study was initially designed to register up to 30 patients from 10 investigational sites in the U.S. However only 11 patients were actually registered and underwent successful implantation with Tendyne TMVI device. Of the 11 patients, 10 patients completed 30-day follow-up, while the remaining one patient died 18 days after the implant procedure

Arm/Group Title	Device Arm
Arm/Group Description	All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
Period Title: Overall Study
STARTED	11
COMPLETED	10
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Device Arm
Arm/Group Description	All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78.2 (5.8)
Age, Customized (participants) [Number]
18-75 years	4 36.4%
>75 years	7 63.6%
Sex: Female, Male (Count of Participants)
Female	7 63.6%
Male	4 36.4%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latino	1 9.1%
Not Hispanic/Latino	10 90.9%
White/Caucasian	10 90.9%
Region of Enrollment (participants) [Number]
United States	11 100%
Predicted Surgical Mortality (Probability percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Probability percentage]	9.03 (8.09)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.3 (5.9)
Renal Insufficiency (GFR < 60 mL/min/1.73m^2) (Count of Participants)
Count of Participants [Participants]	5 45.5%
Peripheral Artery Disease (Count of Participants)
Count of Participants [Participants]	6 54.5%
History of Hypertension (Count of Participants)
Count of Participants [Participants]	10 90.9%
Coronary Artery Disease (Count of Participants)
Count of Participants [Participants]	8 72.7%
Prior Coronary Intervention (Count of Participants)
Count of Participants [Participants]	8 72.7%
Previous Myocardial Infarction (Count of Participants)
Count of Participants [Participants]	3 27.3%
Prior Valve Intervention (Count of Participants)
Count of Participants [Participants]	6 54.5%
LV Measurement (mL) [Mean (Standard Deviation) ]
Left Ventricular End Diastolic Volume (LVEDV)	117.3 (27.1)
Left Ventricular End Systolic Volume (LVESV)	48.7 (18.4)
LV Measurement (cm) [Mean (Standard Deviation) ]
Left Ventricular End Diastolic Diameter (LVEDD)	5.2 (0.4)
Left Ventricular End Systolic Diameter (LVESD)	3.7 (0.6)
Kansas City Cardiovascular Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	46.0 (20.1)
NYHA Functional Class (participants) [Number]
NYHA Functional Class I	0 0%
NYHA Functional Class II	2 18.2%
NYHA Functional Class III	9 81.8%
NYHA Functional Class IV	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)
Description	Definition of Device Success: All of the following must be present: Absence of procedural mortality or stroke; and Proper placement and positioning of the device, and Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee
Time Frame	30 days post implant

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes all subjects that were registered and implanted in the study.

Arm/Group Title	Device Arm
Arm/Group Description	All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
Measure Participants	11
Count of Participants [Participants]	7 63.6%

Adverse Events

Time Frame	30 days
Arm/Group Title	Device Arm
Arm/Group Description	All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
All Cause Mortality
	Device Arm
	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)
Serious Adverse Events
	Device Arm
	Affected / at Risk (%)	# Events
Total	5/11 (45.5%)
Blood and lymphatic system disorders
Bleeding	2/11 (18.2%)
Hemolysis	1/11 (9.1%)
Paravalvular Leak	1/11 (9.1%)
Cardiac disorders
Arrhythmia or conduction disturbance	1/11 (9.1%)
Worsening Congestive Heart Failure	1/11 (9.1%)
Gastrointestinal disorders
Mesenteric Ischemia and Hemorrhagic Shock	1/11 (9.1%)
Nervous system disorders
Stroke/TIA	1/11 (9.1%)
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency/Failure	1/11 (9.1%)
Other (Not Including Serious) Adverse Events
	Device Arm
	Affected / at Risk (%)	# Events
Total	7/11 (63.6%)
Blood and lymphatic system disorders
Bleeding	2/11 (18.2%)
Thrombocytopenia	2/11 (18.2%)
Cardiac disorders
Arrhythmia or Conduction Disturbance	2/11 (18.2%)
Heart Failure treated with IV diuretics	1/11 (9.1%)
Nervous system disorders
Vocal Cord Dysfunction	1/11 (9.1%)
Renal and urinary disorders
Acute Kidney Injury	1/11 (9.1%)
Respiratory, thoracic and mediastinal disorders
Dizziness	1/11 (9.1%)
Pleural Effusion	2/11 (18.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The investigators will not use study-related data without the written consent of the sponsor.