Trial Outcomes & Findings for Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (NCT NCT03433274)

Last Updated: 2026-01-08

Results Overview

The primary endpoint for the Severe MAC cohort is freedom from all-cause mortality and heart failure hospitalization (HFH), evaluated against a performance goal of 43%.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

103 participants

Primary outcome timeframe

12 months post index procedure

Results posted on

2026-01-08

Participant Flow

A total of 103 subjects was registered in the Severe MAC cohort at a total of 37 sites with follow up through 12 months period

Participant milestones

Participant milestones
Measure	Severe Mitral Annular Calcification (MAC) Cohort Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Overall Study STARTED	103
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Severe Mitral Annular Calcification (MAC) Cohort Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Overall Study Withdrawal by Subject	2
Overall Study Missed visit	5
Overall Study Death	23

Baseline Characteristics

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Severe Mitral Annular Calcification (MAC) Cohort n=103 Participants Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Age, Continuous	78 years STANDARD_DEVIATION 6.5 • n=18 Participants
Sex: Female, Male Female	57 Participants n=18 Participants
Sex: Female, Male Male	46 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	2 Participants n=18 Participants
Race (NIH/OMB) White	101 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants
Region of Enrollment Canada	3 Participants n=18 Participants
Region of Enrollment United States	100 Participants n=18 Participants
Hypertension	92 Participants n=18 Participants

PRIMARY outcome

Timeframe: 12 months post index procedure

Population: Attempted procedure (AP) population included subjects in whom a Tendyne procedure was attempted (initial incision for the Tendyne procedure)

The primary endpoint for the Severe MAC cohort is freedom from all-cause mortality and heart failure hospitalization (HFH), evaluated against a performance goal of 43%.

Outcome measures

Outcome measures
Measure	Severe Mitral Annular Calcification (MAC) Cohort n=103 Participants Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Percentage of Participants With Freedom From All-cause Mortality and Heart Failure Hospitalization (HFH)	60.4 percentage of participants -Kaplan Meier Interval 50.2 to 69.2

SECONDARY outcome

Timeframe: At 1 month post index procedure

Population: Attempted procedure (AP) population included subjects in whom a Tendyne procedure was attempted (initial incision for the Tendyne procedure)

Freedom from MR \> mild (1+) in severity at 1 month post index procedure among survivors. The null and alternative hypotheses are stated as: H0: PMR ≤ 1+ ≤ PPG H1: P MR ≤ 1+ \> PPG where PMR ≤ 1+ is the proportion of subjects who have MR ≤ 1+ at 1 months post index procedure.

Outcome measures

Outcome measures
Measure	Severe Mitral Annular Calcification (MAC) Cohort n=98 Participants Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Percentage of Participants With Freedom From Mitral Regurgitation (MR) Severity > 1	100.0 percentage of participants Interval 96.3 to 100.0

SECONDARY outcome

Timeframe: From Baseline at 12 Months

Population: Attempted procedure (AP) population included subjects in whom a Tendyne procedure was attempted (initial incision for the Tendyne procedure), were alive and with available data at 12 Months.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item questionnaire developed to independently measure a patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. It includes questions on symptoms, physical limitations, social relationships, and emotional well-being. The KCCQ was administered by study personnel and completed by the subject. KCCQ scores range from 0-100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.

Outcome measures

Outcome measures
Measure	Severe Mitral Annular Calcification (MAC) Cohort n=74 Participants Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Change in KCCQ Overall Score	69.9 score on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: Change from Baseline at 12 Months

New York Heart Association Classification (NYHA Class): NYHA class is an ordinal variable with higher classes indicating a worse degree of heart failure: Class I Patients with cardiac disease but without resulting limitations of physical activity. Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Outcome measures

Outcome measures
Measure	Severe Mitral Annular Calcification (MAC) Cohort n=72 Participants Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Change in Percentage of Participants With NYHA Class I & II	87.5 percentage of participants Interval 77.6 to 94.1

SECONDARY outcome

Timeframe: From Baseline at 12 Months

To evaluate the benefit of the Tendyne device, the distance walked at 12 months as measured by the 6MWT was compared with that from baseline. The six-minute walk test is a simple cardiopulmonary functional testing modality. Its straightforward nature allows for a non-specific, integrated assessment of the many systems involved during physical activity. Specifically, its results can assist in ascertaining the degree of functional impairment and potentially lead to modifications in therapy for some cardiovascular and pulmonary conditions.

Outcome measures

Outcome measures
Measure	Severe Mitral Annular Calcification (MAC) Cohort n=65 Participants Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Change in Six Minute Walk Test	238.7 meters Standard Deviation 109

Adverse Events

Severe Mitral Annular Calcification (MAC) Cohort

Serious events: 81 serious events

Other events: 3 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Severe Mitral Annular Calcification (MAC) Cohort n=103 participants at risk Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Nervous system disorders Stroke or TIA	3.9% 4/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Surgical and medical procedures Mitral Valve Reintervention	4.9% 5/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Cardiac disorders Myocardial Infarction	0.97% 1/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Injury, poisoning and procedural complications Bleeding	37.9% 39/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Vascular disorders Access Site and Vascular Complications	16.5% 17/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Cardiac disorders Cardiac Structural Complications due to Access Related Issues (MVARC)	9.7% 10/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Renal and urinary disorders Acute Kidney Injury (MVARC)	11.7% 12/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Respiratory, thoracic and mediastinal disorders Respiratory Failure (>48 hour intubation)	8.7% 9/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Cardiac disorders Arrhythmia or Conduction Disturbance	39.8% 41/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Infections and infestations Endocarditis	3.9% 4/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Vascular disorders Device Thrombosis	2.9% 3/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Surgical and medical procedures Emergency Surgery or Intervention during Index Procedure	4.9% 5/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
General disorders Other	49.5% 51/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.

Other adverse events

Other adverse events
Measure	Severe Mitral Annular Calcification (MAC) Cohort n=103 participants at risk Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System.
Vascular disorders HYPOTENSION	0.97% 1/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Cardiac disorders PERICARDITIS	0.97% 1/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.
Gastrointestinal disorders ABDOMINAL PAIN	0.97% 1/103 • Through 1-year A detailed reporting of all deaths, adverse events and device deficiencies through 12 months in the Severe MAC cohort.

Additional Information

Kayla Dellefratte, Senior Manager Clinical Project Management

Abbott

Phone: +16692149748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60