Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment; Prospective Registry

Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment; Prospective Registry - Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment(RESEALED Registry)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033433

Enrollment

Registered

2018-07-18

Start date

2018-07-18

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Post transcatheter closure of paravalvular leak using Occultech PLD device in RESEAL trial

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who were enrolled in RESEAL trial(CTR-096-001, Investigator-led clinical trial to assess safety and efficacy of transcatheter closure of paravalvular leak in high risk symptomatic patients) and completed all required follow-ups 2) Patients who were informed and be abel togive written consent.

Exclusion criteria

Exclusion criteria: 1) Those who are or will be enrolled in other clnical trials. 2) Those who are deemed as inappropriate as subjects of study by institutional investigators.

Design outcomes

Primary

Measure	Time frame
Prognosis of patients underwent transcatheter closure of paravalvular leaks : heart failure admissions, cardiovascular interventions( surgery, catheter intervention, device therapy), mortality(all-cause, cardiovascular)	—

Secondary

Measure	Time frame
Improvement of heart failure as assess by PVL grade,BNP,MLWHFQ,6MWD and NYHA class and improvement of hemolytic anemia as assessed by hemoglobin, reticulocyte, LDH, serum bilirubin.	—

Countries

Japan

Contacts

Public ContactTakeshi Arita

Kyushu University Hospital Heart Center

tarita@med.kyushu-u.ac.jp092-641-1151

Outcome results