Evaluation of a new type of heart valve - a single-center experience

Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14952278

Enrollment

100

Registered

2017-11-08

Start date

2013-09-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with severe symptomatic aortic stenosis with high or extreme surgical risk eligible for TAVI Circulatory System Aortic (valve) stenosis

Interventions

The 30-day and 12-month safety and efficacy of the 100 first successful Lotus Valve implantations will be evaluated in a prospective non-randomized registry.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. >18 years old 2. Eligible for TAVI and eligible for implantation with a Lotus Valve as assessed by the interdisciplinary Heart Team

Exclusion criteria

Exclusion criteria: 1. <18 years old 2. Other co-morbidity with expected life span <12 months

Design outcomes

Primary

Measure	Time frame
Device success according to VARC 2 criteria (periprocedural)	—

Secondary

Measure	Time frame
1. Mortality at 30 days and 12 months 2. Pacemaker implantation rate at discharge, 30 days and 12 months 3. Major vascular complications at discharge 4. Stroke at 30 days 5. Paravalvular leak at discharge and 12 months	—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026