Exercise Training After Transcatheter Aortic Valve Implantation

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2020-12-01

Brief Summary

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

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Detailed Description

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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

Conditions

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Aortic Valve Stenosis TAVI Transcatheter Aortic Valve Implantation Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise training group

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.

Group Type ACTIVE_COMPARATOR

Exercise training

Intervention Type OTHER

Continuous exercise training 2 times per week for a period of 12 weeks.

Usual care group

Patient to be randomized to "usual care group" will undergo standard care fo 12 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

Continuous exercise training 2 times per week for a period of 12 weeks.

Intervention Type OTHER

Other Intervention Names

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Rehabilitation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No