Clinical trial NCT04482816: Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI
Official title: Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI (PHYS-TAVI Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcatheter Aortic Valve Implantation
Physiological Pacing
Right Ventricular Pacing
AV Block
Keywords: TAVI
Physiological Pacing
AV Block
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 24
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.

Eligibility criteria: 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.

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 functional class.
timeFrame: 30 days; 12 months
measure: Change in degree of mitral regurgitation.
timeFrame: 12 months
measure: Change in NTproBNP.
timeFrame: 30 days; 12 months
measure: Hospitalization due to heart failure.
timeFrame: 12 months
measure: QRS duration
timeFrame: Implant; 12 months
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 Clinic de Barcelona
Study officials:
affiliation: Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
name: José M Tolosana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
name: Margarida Pujol Lopez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
name: Lluís Mont, MD, PhD
role: STUDY_DIRECTOR
affiliation: Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
name: Eduard Guasch, MD, PhD
role: STUDY_CHAIR
References: