Active — Not RecruitingNot Applicable

Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study

Georgia, Uzbekistan8 participantsStarted 2024-11-21

Plain-language summary

Early System Experience with the Abbott Balloon-expandable TAVI System

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Increased surgical risk * Appropriate anatomy * At least 18 years of age * Willing to return for follow-up assessments Exclusion Criteria: * Pregnant or nursing subjects * Anatomic or comorbid conditions * Evidence of acute myocardial infarction * Inoperable/ineligible for surgery * Renal disease requiring chronic dialysis

What they're measuring

Technical Success

Timeframe: Post procedure

Device success

Timeframe: 30 days

Trial details

NCT IDNCT07082426

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-30

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