AltaValve Pivotal Trial

Mitral Regurgitation Clinical Trial

Official title:

AltaValve Pivotal Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465745
• Other study ID #: 5472
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2031

Study information

• Verified date: June 2024
• Source: 4C Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: September 2031
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.
• Symptomatic New York Heart Association (NYHA) class II-IV.
• Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
• Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.

Exclusion Criteria (Abbreviated List):

• Inability to understand the trial or a history of non-compliance with medical advice.
• Inability to provide signed Informed Consent Form (ICF).
• History of any cognitive or mental health status that would interfere with participation in the trial.
• Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
• Female subjects who are pregnant or planning to become pregnant within the trial period.
• Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
• Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
• Known hypersensitivity to contrast media that cannot be adequately medicated.
• Evidence of current left ventricular ejection fraction (LVEF) = 25%.
• Concurrent medical condition with a life expectancy of less than 12 months.
• Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
• Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.

Related Conditions & MeSH terms

• Mitral Incompetence
• Mitral Insufficiency
• Mitral Regurgitation
• Mitral Valve Incompetence
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• AltaValve System.
Transcatheter Mitral Valve Replacement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
4C Medical Technologies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality or heart failure hospitalization.		12 months.
Secondary	All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention.	Composite.	30 Days or hospital discharge (whichever is longer).
Secondary	Technical success.	Technical success will be considered achieve when all of the following are present: Successful application of the delivery system as intended.; Successful device placement.; Reduction in mitral regurgitation grade to = 2+.	Day 0.
Secondary	Mitral valve re-intervention.	Mitral valve re-intervention after index procedure	At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.
Secondary	Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).	Quality of life improvement.	6 months and 1 year.
Secondary	Changes in Six-minute walk test (6MWT).	Quality of life improvement.	6 months and 1 year.
Secondary	New pacemaker rate.		1 month, 6 months and 1 year.