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Completed

NCT Number: NCT04482816

Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI

Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.

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Key information

Conditions

Transcatheter Aortic Valve Implantation AV Block Arrhythmias, Cardiac Atrioventricular Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Physiological Pacing Right Ventricular Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, Spain

About this study

There is currently no evidence of the best mode of definitive pacing after TAVI in patients with preserved systolic ventricular function and AV block. Through this study, investigators intend to elucidate the best post TAVI pacing strategy, comparing the effect of right apical pacing vs. physiological pacing on the evolution of both echocardiographic and clinical parameters.

Investigators will include 24 patients without ventricular dysfunction (LVEF> 50%) and with AV block pacing indication after TAVI.

Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological or right ventricular pacing (conventional).

PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class; distance in the 6-minute walking test; hospital admissions; left ventricular function; echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12)

Clinical, and echocardiographic follow-up will be performed for 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Successful implantation of TAVI according to VARC-2 criteria.
  • Indication of cardiac pacing due to AV block according to ESC Guidelines.
  • LVEF> 50%.
  • The patient must indicate their acceptance to participate in the study by signing an informed consent document.

Exclusion criteria

  • Ventricular dysfunction: LVEF <50%.
  • Transapical TAVI.
  • Participating currently in a clinical investigation that includes an active treatment.
  • Patients with left bundle branch block but without indication of pacing (AV block).
  • Life expectancy <12 months.

Treatment and study plan

Physiological pacing

Device

Pacing of the his bundle or the left bundle branch

Right Ventricular Pacing

Device

Conventional pacing; right ventricular pacing

Primary outcomes

  1. Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.

    Time frame: 12 months

    Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.

Secondary outcomes

  1. Change in left ventricular ejection fraction.

    Time frame: 12 months

    Left ventricular ejection fraction (LVEF %) measured with Simpson method with echocardiography (Delta left ventricular ejection fraction: 12 months LVEF - baseline LVEF).

  2. Correction of echocardiographic asynchrony: septal flash expressed in mm.

    Time frame: 30 days; 12 months

    Correction of septal flash determined with echocardiography (M mode).

  3. Distance covered in the 6-minute walking test.

    Time frame: 30 days; 12 months

    Distance in meters walked in 6 minutes.

  4. Change in NYHA functional class.

    Time frame: 30 days; 12 months

    NYHA functional class I, II, III, IV.

  5. Change in degree of mitral regurgitation.

    Time frame: 12 months

    Mitral regurgitation measured with echocardiography.

  6. Change in NTproBNP.

    Time frame: 30 days; 12 months

    NTproBNP blood levels.

  7. Hospitalization due to heart failure.

    Time frame: 12 months

    Hospitalization: patient hospitalization (yes/no).

  8. QRS duration

    Time frame: Implant; 12 months

    QRS duration (milliseconds) measured with a 12-lead ECG (in the electrophysiology lab polygraph)

  9. Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire )

    Time frame: 30 days; 12 months

    Score in KCCQ-12: higher=better.

  10. Correction of global longitudinal strain

    Time frame: 30 days; 12 months

    Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography

Sponsors and collaborators

Lead sponsor

Josep Lluis Mont Girbau

Other

Registry information

Official study title

Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI (PHYS-TAVI Trial)

Acronym: PHYS-TAVI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2020
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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