Clinical trial NCT06197503: Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI
Official title: Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcatheter Aortic Valve Implantation
Physiological Pacing
Right Ventricular Pacing
AV Block
Preserved Left Ventricular Systolic Function
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
timeFrame: 12 months
Secondary outcomes:
measure: Change in left ventricular ejection fraction.
timeFrame: 12 months.
measure: Correction of echocardiographic asynchrony: septal flash expressed in mm.
timeFrame: 30 days; 12 months.
measure: Distance covered in the 6-minute walking test.
timeFrame: 30 days; 12 months.
measure: Change in NYHA (New York Heart Association) functional class.
timeFrame: 30 days; 12 months.
measure: Change in degree of mitral regurgitation.
timeFrame: 30 days; 12 months.
measure: Change in NTproBNP.
timeFrame: Baseline; 12 months.
measure: Hospitalization due to heart failure.
timeFrame: 12 months.
measure: QRS duration.
timeFrame: Baseline
measure: Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire).
timeFrame: 30 days; 12 months.
measure: Correction of global longitudinal strain
timeFrame: 30 days; 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clínic de Barcelona. IDIBAPS
name: Lluís Mont, MD, PhD
role: STUDY_DIRECTOR
References: