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NCT Number: NCT06197503

Randomized Study of 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 Preserved Left Ventricular Systolic Function Right Ventricular Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location status: Recruiting

Location contact

Lluís Mont, MD, PhD

CONTACT

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.

Inclusion of 24 more patients to those already included in the context of PHYSTAVI I (NCT04482816). Exploratory trial.

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-3 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

Conduction system pacing

Procedure

Left bundle branch pacing or His bundle branch pacing

Right ventricular pacing

Procedure

Conventional 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 (New York Heart Association) functional class.

    Time frame: 30 days; 12 months.

    NYHA functional class I, II, III, IV.

  5. Change in degree of mitral regurgitation.

    Time frame: 30 days; 12 months.

    Mitral regurgitation (MR) measured with echocardiography. The severity of MR graded as absent (0), mild (1), moderate (2), moderate-severe (3), or severe (4).

  6. Change in NTproBNP.

    Time frame: Baseline; 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: Baseline

    QRS duration (milliseconds) measured with a 12-lead ECG (200mm/s).

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

    Time frame: 30 days; 12 months.

    Score in Kansas City Cardiomyopathy Questionnaire-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

Study contacts

Contact information is provided by the study sponsor or research team.

Lluís Mont, MD, PhD

CONTACT

[email protected]

93 2271778 Ext. 2094

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)

Acronym: PHYSTAVIII

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2024
Registry last updated
Mar 31, 2026

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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