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

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

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.

Study Overview

• Status: Recruiting
• Conditions: AV Block; Transcatheter Aortic Valve Implantation; Physiological Pacing; Right Ventricular Pacing; Preserved Left Ventricular Systolic Function
• Intervention / Treatment: Procedure: Conduction system pacing; Procedure: Right ventricular pacing

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.

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

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lluís Mont, MD, PhD; Phone Number: 93 2271778 Ext. 2094; Email: lmont@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic De Barcelona
    • Contact: Lluís Mont, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right ventricular pacing; Lead placed in the right ventricle (conventional pacing).	Procedure: Right ventricular pacing; Conventional pacing
Experimental: Conduction system pacing; Lead placed in the His-Purkinje system (His or left bundle branch) in order to achieve QRS shortening and physiologic pacing. Crossover from physiological pacing to right ventricular pacing will be allowed in case of failed His bundle pacing or left bundle branch pacing.	Procedure: Conduction system pacing; Left bundle branch pacing or His bundle branch pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correction of global longitudinal strain	Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography	30 days; 12 months
Change in left ventricular ejection fraction.	Left ventricular ejection fraction (LVEF %) measured with Simpson method with echocardiography (Delta left ventricular ejection fraction: 12 months LVEF - baseline LVEF).	12 months.
Correction of echocardiographic asynchrony: septal flash expressed in mm.	Correction of septal flash determined with echocardiography (M mode).	30 days; 12 months.
Distance covered in the 6-minute walking test.	Distance in meters walked in 6 minutes.	30 days; 12 months.
Change in NYHA (New York Heart Association) functional class.	NYHA functional class I, II, III, IV.	30 days; 12 months.
Change in degree of mitral regurgitation.	Mitral regurgitation (MR) measured with echocardiography. The severity of MR graded as absent (0), mild (1), moderate (2), moderate-severe (3), or severe (4).	30 days; 12 months.
Change in NTproBNP.	NTproBNP blood levels.	Baseline; 12 months.
Hospitalization due to heart failure.	Hospitalization: patient hospitalization (yes/no).	12 months.
QRS duration.	QRS duration (milliseconds) measured with a 12-lead ECG (200mm/s).	Baseline
Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).	Score in Kansas City Cardiomyopathy Questionnaire-12: (higher=better).	30 days; 12 months.

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Study Director: Lluís Mont, MD, PhD, Hospital Clínic de Barcelona. IDIBAPS

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): December 15, 2025
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: December 9, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Pathological Conditions, Signs and Symptoms; Atrioventricular Block
• Other Study ID Numbers: PHYSTAVI II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No