Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conduction system pacing, Right ventricular pacing.
- Who it may be relevant to
- Registry conditions: Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)
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.
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.
Interventions
- Procedure Conduction system pacing
Left bundle branch pacing or His bundle branch pacing - Procedure Right ventricular pacing
Conventional pacing
Primary outcome 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]
Secondary outcome measures (10)
- Change in left ventricular ejection fraction. [Time frame: 12 months.]
- Correction of echocardiographic asynchrony: septal flash expressed in mm. [Time frame: 30 days; 12 months.]
- Distance covered in the 6-minute walking test. [Time frame: 30 days; 12 months.]
- Change in NYHA (New York Heart Association) functional class. [Time frame: 30 days; 12 months.]
- Change in degree of mitral regurgitation. [Time frame: 30 days; 12 months.]
- Change in NTproBNP. [Time frame: Baseline; 12 months.]
- Hospitalization due to heart failure. [Time frame: 12 months.]
- QRS duration. [Time frame: Baseline]
- Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire). [Time frame: 30 days; 12 months.]
- Correction of global longitudinal strain [Time frame: 30 days; 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Clínic de Barcelona — Barcelona
Identifiers
NCT: NCT06197503 · PHYSTAVI II