NCT03728049

Brief Summary

Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation. The hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
944

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

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 Progress92%
Dec 2019Dec 2026

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 18, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

7 years

First QC Date

October 30, 2018

Last Update Submit

May 20, 2026

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Keywords

Transcatheter Aortic Valve ReplacementParavalvular regurgitationPoint-of-care testBiomarkerAortic stenosisVon willebrand Factor

Outcome Measures

Primary Outcomes (1)

  • composite 1-year event rate of

    rate of All-cause death; rate of Paravalvular regurgitation ≥ moderate; rate of Rehospitalization; rate of Stroke; rate of Delayed valve re-intervention; rate of Mean transaortic gradient \>20mmHg.

    At 1 year

Secondary Outcomes (12)

  • All-cause death rate

    At 30 days, at 1 year

  • PVR rate

    At 30 days, at 1 year

  • Rehospitalization for heart failure rate

    At 30 days, at 1 year

  • Delayed valve re-intervention rate

    At 1 year

  • Delayed valve re-intervention rate

    At 30 days, at 1 year

  • +7 more secondary outcomes

Study Arms (2)

CT-ADP group

EXPERIMENTAL

PVR assessment with the standard methods and with the CT-ADP that will be provided to the operator in real-time during TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator and based on the results of the CT-ADP on top of the standard methods of PVR assessment.

Diagnostic Test: CT-ADP performed during TAVI procedure

Control group

OTHER

PVR assessment with standard methods only (at discretion of the operator excluding CT-ADP and transesophageal echocardiography). CT-ADP will not be provided to the operator at the time of TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator according to the results of the standard methods of PVR assessment.

Other: No CT-ADP performed during TAVI procedure

Interventions

CT-ADP performed during TAVI procedureDIAGNOSTIC_TEST

The CT-ADP will be performed in the catheterization laboratory and revealed to the operator. The decision to undertake corrective procedure will be based on CT-ADP on top of standard methods of PVR assessment.

CT-ADP group
No CT-ADP performed during TAVI procedureOTHER

PVR assessment with the standard methods only (TTE and/or angiography and/or hemodynamics but excluding TEE and CT-ADP). The decision to undertake corrective procedure will be left at the discretion of the operator.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic aortic stenosis scheduled to undergo TAVI
  • TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no TEE guidance.
  • All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted

You may not qualify if:

  • TAVI through non-transfemoral approach
  • TAVI with concomitant percutaneous coronary intervention
  • TAVI performed under general anesthesia
  • TAVI performed under TEE guidance
  • Valve-in-valve procedure
  • Inability to provide informed consent
  • Associated ≥ moderate mitral regurgitation
  • Peri-procedural treatment with ticagrelor or prasugrel treatment / direct oral anticoagulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hopital Estaing - Chu63 - Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

Institut Coeur-Poumon, CHU

Lille, 59037, France

RECRUITING

Chu Montpellier

Montpellier, France

NOT YET RECRUITING

CHU de Nimes

Nîmes, France

NOT YET RECRUITING

Hu Pitie Salpetriere Aphp - Paris 13

Paris, France

NOT YET RECRUITING

Hopital Haut-Leveque - Chu - Pessac

Pessac, 33604, France

RECRUITING

Chru Rennes Site Pontchaillou

Rennes, France

NOT YET RECRUITING

Hopital Civil / Nouvel Hopital Civil - Strasbourg

Strasbourg, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Eric Vanbelle, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Van Belle, MD,PhD

CONTACT

03 20 44 50 15eric.vanbelle2@chru-lille.fr

Flavien Vincent, MD, PhD

CONTACT

03 20 44 59 62 (31588)flavien.vincent@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter open-label randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 1, 2018

Study Start

December 18, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

FR(9)