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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block

Intervention / Treatment
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* Device: Physiological pacing
* Device: Right ventricular pacing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiological pacing<br>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<br>* Pacing of the his bundle or the left bundle branch<br>|
| Active Comparator: Right ventricular pacing<br>Lead placed in the right ventricle (conventional pacing). | Device: Right ventricular pacing<br>* Conventional pacing; right ventricular pacing<br>|

What is the study measuring?
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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 | 
| Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire ) | Score in KCCQ-12: higher=better. | 30 days; 12 months | 
| Correction of global longitudinal strain | Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography | 30 days; 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Physiological Pacing, AV Block