NCT03847948

Brief Summary

A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI). \- The main objective is to determine whether the high residual platelet reactivity rates in patients undergoing TAVI is associated with the occurrence of clinical and / or subclinical prosthetic valve thrombosis measured by echocardiography and multi-slice computerized tomography

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

3.6 years

First QC Date

February 3, 2019

Last Update Submit

October 28, 2021

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis

    platelet reactivity will be measured with the commercial kit platelet Vasodilator Stimulated Phosphoprotein (VASP)/P2Y12 and subclinical valve thrombosis by transthoracic echocardiography and multi-slice computerized tomography

    at 3 months

Secondary Outcomes (5)

  • To measure the variability of platelet aggregation

    at baseline, 1 day post-procedure and at 3-6 months and 1 year follow-up.

  • To quantify the pro-thrombotic inflammatory response

    at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.

  • To correlate of Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis

    at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.

  • To correlate residual platelet reactivity with clinical events

    at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up.

  • To evaluate clinical factors associated with the appearance of early prosthetic thrombosis.

    multi slice computerized tomography at 3 month and clinical up to 1 year.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with severe symptomatic aortic stenosis treated with TAVI

You may qualify if:

  • Patients with severe symptomatic aortic stenosis who it was accepted to be treated with TAVI by a multidisciplinary team "Heat Team".
  • TAVI was successfully implanted (according to Valve Academic Research Consortium II criteria) and are under treatment with double antiplatelet therapy.
  • Signed informed consent to participate in this study.

You may not qualify if:

  • Age under 18 years and pregnant or of childbearing age.
  • Acute Recent stroke recent \<14 days before TAVI.
  • The patients with proven allergy to aspirin, clopidogrel
  • Patients that after TAVI cannot undergo a double antiplatelet regimen for 6 months due to a new post-TAVI medical indication or are anticoagulated.
  • Knowledge of pregnancy or lactation Thrombocytopenia (\<50,000 platelets U / L) well documented and clinically relevant.
  • The patients with documented moderate or severe hepatic insufficiency
  • Severe chronic renal insufficiency with creatinine clearance \<30 ml / min.
  • The patients who can not attend the follow-up visits scheduled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clinic

Barcelona, Spain

NOT YET RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

February 3, 2019

First Posted

February 20, 2019

Study Start

June 1, 2018

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)