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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 2023

Detailed Description

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.

Interventions

  • Device: Physiological pacing
    • Pacing of the his bundle or the left bundle branch
  • Device: Right ventricular pacing
    • Conventional pacing; right ventricular pacing

Arms, Groups and Cohorts

  • Experimental: Physiological pacing
    • Lead placed in the His-Purkinje system (his or branch) in order to achieve QRS shortening and physiologic pacing. A backup lead will be implanted in the right ventricle. If hisian pacing is not achieved (QRS is not shortened > 20% or QRS is not <130ms), the left bundle branch will be paced according to the criteria established in the literature (right branch block and intrinsic deflection <85ms). Crossover from physiological pacing to right ventricular pacing will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (>3.5V / 1ms); no shortening of QRS (shortening <20%) or failure to meet non-selective HBP criteria or left bundle branch pacing criteria.
  • Active Comparator: Right ventricular pacing
    • Lead placed in the right ventricle (conventional pacing).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).
  • Correction of echocardiographic asynchrony: septal flash expressed in mm.
    • Time Frame: 30 days; 12 months
    • Correction of septal flash determined with echocardiography (M mode).
  • Distance covered in the 6-minute walking test.
    • Time Frame: 30 days; 12 months
    • Distance in meters walked in 6 minutes.
  • Change in NYHA functional class.
    • Time Frame: 30 days; 12 months
    • NYHA functional class I, II, III, IV.
  • Change in degree of mitral regurgitation.
    • Time Frame: 12 months
    • Mitral regurgitation measured with echocardiography.
  • Change in NTproBNP.
    • Time Frame: 30 days; 12 months
    • NTproBNP blood levels.
  • Hospitalization due to heart failure.
    • Time Frame: 12 months
    • Hospitalization: patient hospitalization (yes/no).
  • QRS duration
    • Time Frame: Implant; 12 months
    • QRS duration (milliseconds) measured with a 12-lead ECG (in the electrophysiology lab polygraph)
  • Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire )
    • Time Frame: 30 days; 12 months
    • Score in KCCQ-12: 23 items; scores 1 – 100 (higher=better).
  • Correction of global longitudinal strain
    • Time Frame: 30 days; 12 months
    • Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Josep Lluis Mont Girbau
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Josep Lluis Mont Girbau, Head of Arrhythmia Section. Professor of Cardiology – Hospital Clinic of Barcelona
  • Overall Official(s)
    • José M Tolosana, MD, PhD, Principal Investigator, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
    • Margarida Pujol Lopez, MD, Principal Investigator, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
    • Lluís Mont, MD, PhD, Study Director, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
    • Eduard Guasch, MD, PhD, Study Chair, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
  • Overall Contact(s)
    • Margarida Pujol Lopez, MD, 93 2271778, mapujol@clinic.cat

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