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

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

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: Completed
• Conditions: AV Block; Transcatheter Aortic Valve Implantation; Physiological Pacing; Right Ventricular Pacing
• Intervention / Treatment: Device: Physiological pacing; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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
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.	Device: Physiological pacing; Pacing of the his bundle or the left bundle branch
Active Comparator: Right ventricular pacing; Lead placed in the right ventricle (conventional pacing).	Device: Right ventricular pacing; Conventional pacing; right ventricular 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
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 functional class.	NYHA functional class I, II, III, IV.	30 days; 12 months
Change in degree of mitral regurgitation.	Mitral regurgitation measured with echocardiography.	12 months
Change in NTproBNP.	NTproBNP blood levels.	30 days; 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 (in the electrophysiology lab polygraph)	Implant; 12 months
Correction of global longitudinal strain	Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography	30 days; 12 months
Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire )	Score in KCCQ-12: higher=better.	30 days; 12 months

Collaborators and Investigators

• Sponsor: Josep Lluis Mont Girbau
• Investigators: Principal Investigator: José M Tolosana, MD, PhD, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.; Principal Investigator: Margarida Pujol Lopez, MD, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.; Study Director: Lluís Mont, MD, PhD, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.; Study Chair: Eduard Guasch, MD, PhD, Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 18, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 9, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: TAVI; AV Block; Physiological Pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrioventricular Block
• Other Study ID Numbers: PHYS-TAVI TRIAL

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
• product manufactured in and exported from the U.S.: No