---
title: Exercise Training After Transcatheter Aortic Valve Implantation
nct_id: NCT03966417
overall_status: COMPLETED
phase: NA
sponsor: University Medical Centre Ljubljana
study_type: INTERVENTIONAL
primary_condition: Aortic Valve Stenosis
countries: Slovenia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03966417.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03966417"
ct_last_update_post_date: 2022-11-01
last_seen_at: "2026-05-12T06:49:58.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Exercise Training After Transcatheter Aortic Valve Implantation

**NCT ID:** [NCT03966417](https://clinicaltrials.gov/study/NCT03966417)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** University Medical Centre Ljubljana
- **Conditions:** Aortic Valve Stenosis, TAVI, Transcatheter Aortic Valve Implantation, Rehabilitation
- **Start Date:** 2019-06-18
- **Completion Date:** 2020-12-01
- **CT.gov Last Update:** 2022-11-01

## Brief Summary

In this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.

## Detailed Description

Patients after transcatheter aortic valve replacement (TAVI) are particularly old and severely deconditioned and are thus likely to benefit from cardiac rehabilitation programs. In this controlled trial, patients after TAVI will be randomized to either exercise training or usual care.

The aim of our study is to compare the effect of exercise training vs. usual care on:

1. exercise capacity
2. vascular function
3. parameters of heart failure, inflammation and homeostasis
4. arrhythmogenic potential
5. health-related quality of life

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* TAVI procedure 3-6 months prior to inclusion,
* movability (100 meters or more on 6-minute walking test after TAVI),
* ability to attend a 12 week exercise training program,
* physical and clinical ability to attend the rehabilitation program at the discretion of the researcher,
* optimal medical treatment,
* pre-signed statement of a conscious and free consent to the inclusion in the clinical trial.

Exclusion Criteria:

* contraindications for exercise training,
* unstable hearth (uncontrollable heart failure - New York Heart Association stage IV, dysrhythmias, uncontrollable myocardial ischemia),
* patient's decision to undergo TAVI despite receiving a recommendation for Surgical Aortic Valve Repair by the heart team,
* non-cardiac physical impairment that would prevent exercise training on stationary bike,
* uncontrolled pulmonary disease (FEV1 \<50%),
* echocardiographic signs of prosthesis dysfunction according to the Valve Academic Research Consortium (valve orifice area of b1.2 cm2 plus a mean transaortic pressure gradient of ≥20 mm Hg, or a velocity of ≥3 m/s, at least moderate paravalvular regurgitation),
* TAVI access site complication,
* important peripheral vascular disease, musculoskeletal disease or central nervous system disease, which prevents exercise training on stationary bike,
* recent (less than 3 months) acute events or illnesses that are contraindications for exercise training.
```

## Arms

- **Exercise training group** (ACTIVE_COMPARATOR) — Patient to be randomized to "exercise training group" will have exercise training sessions 2 times per week for a period of 12 weeks. They will undergo moderate continuous exercise training at 75% of Vo2max.
- **Usual care group** (NO_INTERVENTION) — Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.

## Interventions

- **Exercise training** (OTHER) — Continuous exercise training 2 times per week for a period of 12 weeks.

## Primary Outcomes

- **Change of maximal oxygen uptake during exercise** _(time frame: 3 months)_ — ml/kg/min

## Secondary Outcomes

- **Change of flow-mediated dilatation (FMD) of the brachial artery** _(time frame: 3 months)_
- **Change of arterial stiffness coefficient** _(time frame: 3 months)_
- **Change of value of blood N terminal-proBNP** _(time frame: 3 months)_
- **Change of value of blood D-dimer** _(time frame: 3 months)_
- **Change of value from-the-questionnaire-obtained quality of life** _(time frame: 3 months)_
- **Change of ECG waves** _(time frame: 3 months)_
- **Change in the result of the 6-minute walking test** _(time frame: 3 months)_
- **Change og the heart rate variability** _(time frame: 3 months)_

## Locations (1)

- UMC Ljubljana, Ljubljana, Slovenia

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — 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)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.umc ljubljana|ljubljana||slovenia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03966417.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03966417*  
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