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

Not Applicable

Completed

• Conditions: AV Block; Transcatheter Aortic Valve Implantation; Physiological Pacing; Right Ventricular Pacing
• Interventions: Device: Right ventricular pacing; Device: Physiological pacing

• Registration Number: NCT04482816
• Lead Sponsor: Josep Lluis Mont Girbau

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-18
• Study First Posted: 2020-07-23
• Study Start: 2020-09-14
• Primary Completion: 2023-06-30
• Study Completion: 2023-10-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-09
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right ventricular pacing	Right ventricular pacing	Lead placed in the right ventricle (conventional pacing).
Physiological pacing	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.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain