Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2022
Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.
Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04618718 (Cerebral Protection in Transcatheter Aortic Valve Replacement - The PROTEMBO C Trial), which is not on this map. Cited by 16 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cerebral Protection in Transcatheter Aortic Valve Replacement - The PROTEMBO C Trial
Who cites it
16 citing papers in PubMed, 21 citations in OpenAlex.
- Cerebrovascular Events in Aortic Stenosis: From Native Valve Disease to TAVR-Specific Risk and Prevention.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Review
- Enhancing Stroke Prevention in Transcatheter Aortic Valve Replacement: The Role of F2, a Novel Neuroprotection Device.Cardiovascular engineering and technology · 2025Article
- Stroke in Transcatheter Aortic Valve Implantation (TAVI): A Comprehensive Review.Journal of clinical medicine · 2025Review
- The Next Chapter in TAVR: Innovations and the Road Ahead.Journal of clinical medicine · 2025Review
- Embolic Protection Devices in Transcatheter Aortic Valve Implantation: A Narrative Review of Current Evidence.Journal of clinical medicine · 2025Review
- Neuroprotection Devices in Cardiac Catheterization Laboratories: Does It Sufficiently Protect Our Patients?Medicina (Kaunas, Lithuania) · 2025Review
- 2024 Update on Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement.Journal of clinical medicine · 2024Review
- Cerebral Embolic Protection Devices: Are There Any Indications in Transcatheter Aortic Valve Replacement?Journal of clinical medicine · 2024Review
- Final report of the PROTEMBO C Trial: a prospective evaluation of a novel cerebral protection device during TAVI.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Article
- Transcatheter Aortic Valve Replacement: Current Status and Future Indications.Journal of clinical medicine · 2024Review
- The efficacy of different types of cerebral embolic protection device during transcatheter aortic valve implantation: a meta-analysis.Frontiers in cardiovascular medicine · 2024Review
- Cerebral embolic protection during transcatheter heart interventions.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023Review
- Fighting Cardiac Thromboembolism during Transcatheter Procedures: An Update on the Use of Cerebral Protection Devices in Cath Labs and EP Labs.Life (Basel, Switzerland) · 2023Review
- An Updated Meta-Analysis on Cerebral Embolic Protection in Patients Undergoing Transcatheter Aortic Valve Intervention Stratified by Baseline Surgical Risk and Device Type.Structural heart : the journal of the Heart Team · 2023Article
- Transcatheter Aortic Valve Replacement in Elderly Patients: Opportunities and Challenges.Journal of cardiovascular development and disease · 2023Review
- Stroke prevention during and after transcatheter aortic valve implantation: From cerebral protection devices to antithrombotic management.Frontiers in cardiovascular medicine · 2022Review
Corrections and comments
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Authors and funding
18 authors at 9 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction.
aimsThe PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients.
methodsForty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data.
resultsThirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat [ITT] population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval [CI]: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm
conclusionsThe PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.