---
title: Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
nct_id: NCT00986193
overall_status: TERMINATED
phase: NA
sponsor: Aarhus University Hospital Skejby
study_type: INTERVENTIONAL
primary_condition: Aortic Valve Stenosis
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00986193.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00986193"
ct_last_update_post_date: 2017-06-01
last_seen_at: "2026-05-12T06:38:45.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

**Official Title:** Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

**NCT ID:** [NCT00986193](https://clinicaltrials.gov/study/NCT00986193)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** By recommendation from the Data and safety monitoring board
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 72
- **Lead Sponsor:** Aarhus University Hospital Skejby
- **Collaborators:** Odense University Hospital, Danish Heart Foundation
- **Conditions:** Aortic Valve Stenosis
- **Start Date:** 2008-12
- **Completion Date:** 2016-04
- **CT.gov Last Update:** 2017-06-01

## Brief Summary

This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.

## Detailed Description

The purpose of the study is to compare the new established apical stent valve treatment with conventional surgical intervention using biological valve prostheses in patients with severe aortic valve stenosis.

The Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards Lifesciences, Irvine, CA).

Heart centres in the Nordic region with experience (\>10 cases) in apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.

Study hypothesis:

As compared to conventional aortic valve substitution in patients aged \>75 years, apical stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of dialysis for renal failure 1 month after the treatment.

Primary clinical end-point:

Combined end-point consisting of death, CVI and/or renal failure with need for haemodialysis, 1 month after index treatment.

## Eligibility

- **Minimum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Significant aortic valve stenosis (valve area \< 1cm2)
* Age \> 75 (years Aarhus University Hospital, Skejby)
* Age \> 80 years (other participating centres)
* Operable by conventional surgery AND transapical stent valve implantation
* Expected survival \> 1 year following successful treatment
* Accept of participation and in follow-up investigations after adequate information
* Informed consent

Exclusion Criteria:

* Coronary artery disease requiring PCI or CABG
* Earlier cardiac surgery
* Myocardial infarction within 24 hours
* Kidney failure requiring any dialysis
* Ongoing infection
* Acute surgery
* Allergy to ASA or Clopidogrel
```

## Arms

- **Conventional Aortic Valve Surgery** (ACTIVE_COMPARATOR) — Insertion of a biological valve
- **Transapical Aortic Valve Implantation** (EXPERIMENTAL) — Transapical implantation of an Edwards SAPIENtm valve

## Interventions

- **Transapical Aortic Valve Implantation** (PROCEDURE) — Insertion of a stent valve using catheter-based technique through a mini thoracotomy
- **Conventional Aortic Valve Surgery** (PROCEDURE) — Operation using heart-lung machine, with insertion of a biological artificial heart valve

## Primary Outcomes

- **Death, CVI and/or renal failure requiring any dialysis** _(time frame: 1 month)_

## Secondary Outcomes

- **Echocardiographic results, valve performance** _(time frame: 1 month with subseguent followup)_

## Locations (1)

- Aarhus University Hospital, Skejby, Aarhus N, Central Jutland, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.aarhus university hospital, skejby|aarhus n|central jutland|denmark` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00986193.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00986193*  
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