Exercise Training After Transcatheter Aortic Valve Implantation (FitTAVI)

University Medical Centre Ljubljana

Status: Completed

Conditions: Transcatheter Aortic Valve Implantation; Rehabilitation; Aortic Valve Stenosis; TAVI

Treatments: Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT03966417

UKCLFitTAVI

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Exercise training group

Active Comparator group

Description:

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.

Treatment:

Other: Exercise training

Usual care group

No Intervention group

Description:

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