MedDataX Logo

Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)

NCT ID: NCT05774691

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking.

The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of all-cause mortality or clinically relevant bleeding within 30 days after transcatheter aortic valve implantation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Antagonization of Heparin With Protamine Sulfate After TAVI

NCT06215378

Aortic Valve Stenosis Heart Valve Diseases
RECRUITING PHASE3

Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

NCT04437303

Aortic Valve Disease Aortic Valve Stenosis Stroke +4 more
COMPLETED PHASE4

Protamine Sulfate During Transcatheter Aortic Valve Implantation

NCT02974660

Aortic Valve Stenosis
COMPLETED PHASE4

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

NCT05078619

Valvular Heart Disease Aortic Valve Stenosis Coronary Artery Disease
ACTIVE_NOT_RECRUITING NA

Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery

NCT06254404

Protamine Dose Protamine Adverse Reaction
NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Routine protamine administration

Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.

Group Type ACTIVE_COMPARATOR

Protamine sulfate

Intervention Type DRUG

Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.

Selective protamine administration

Selective protamine administration, in case of (threatening) bleeding.

Group Type ACTIVE_COMPARATOR

Protamine sulfate

Intervention Type DRUG

Selective protamine administration, in case of (threatening) bleeding

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Protamine sulfate

Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.

Intervention Type DRUG

Protamine sulfate

Selective protamine administration, in case of (threatening) bleeding

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Routine heparin reversal Selective heparin reversal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged \> 18 years
* Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
* Provided written informed consent

Exclusion Criteria

* Documented protamine allergy or anaphylaxis
* Recent PCI (\< 3 months before TAVI)
* Planned arterial access via surgical cut-down
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Antonius Research Fund

UNKNOWN

Sponsor Role collaborator

St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jurriën M. ten Berg, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

A.S.Z. Aalst

Aalst, , Belgium

Site Status RECRUITING

University Hospitals Leuven

Leuven, , Belgium

Site Status RECRUITING

Maastricht UMC

Maastricht, Limburg, Netherlands

Site Status NOT_YET_RECRUITING

Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status RECRUITING

Amsterdam University Medical Center

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Prof. J.M. ten Berg, MD, PhD

Role: CONTACT

[email protected]
0031 088 320 3000

D.C. Overduin, MD

Role: CONTACT

[email protected]
0031 088 320 3000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

M. Delewi, MD, PhD

Role: primary

Dr. L. Rosseel, MD, PhD

Role: primary

Prof. C. Dubois, MD, PhD

Role: primary

Dr. P. Vriesendorp, MD, PhD

Role: primary

Drs. J. Montero- Cabezas, MD

Role: primary

Drs. F. van der Kley, MD

Role: backup

Prof. J.M. ten Berg, MD, PhD, MSc

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-504205-36-00

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation
NCT05672823 COMPLETED NA
Acute STROke Complicating TAVI - Management and Outcomes
NCT05241821 COMPLETED
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation
NCT06168370 RECRUITING NA
Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography (RETORIC)
NCT02826200 UNKNOWN PHASE4
Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI
NCT03001960 UNKNOWN PHASE3
RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
NCT05036018 ACTIVE_NOT_RECRUITING NA
Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
NCT03588247 COMPLETED
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
NCT01531374 COMPLETED NA
Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery
NCT04205474 COMPLETED NA
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
NCT02080299 UNKNOWN PHASE2
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
NCT02737150 UNKNOWN NA
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
NCT03112980 ACTIVE_NOT_RECRUITING NA
Portico TAVI Implant With Transfemoral Delivery System
NCT01493284 COMPLETED NA
Cardioprotective Effect of RIPC in Patients Undergoing TAVI
NCT02283398 WITHDRAWN NA
The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
NCT01375335 SUSPENDED PHASE4
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
NCT04310046 ACTIVE_NOT_RECRUITING NA
A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis
NCT07108478 NOT_YET_RECRUITING
Portico Valve-in-Valve Retrospective Registry
NCT05002088 COMPLETED
Optimized Expansion of the Implanted Transcatheter Aortic Valve
NCT07042529 RECRUITING NA
Future Optimal Research and Care Evaluation - Aortic Stenosis
NCT06168123 RECRUITING
Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
NCT03740425 COMPLETED
Fast Track Concept for Transfemoral TAVI
NCT04792827 COMPLETED
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
NCT05708118 UNKNOWN
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
NCT05261204 ENROLLING_BY_INVITATION
Conscious Sedation vs General Anesthesia in TAVR Patients
NCT03084978 WITHDRAWN NA