AV Block, Physiological Pacing, Preserved Left Ventricular Systolic Function, Right Ventricular Pacing, Transcatheter Aortic Valve Implantation
Conditions
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.
Interventions
PROCEDUREConduction system pacing
Left bundle branch pacing or His bundle branch pacing
PROCEDURERight ventricular pacing
Conventional pacing
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in NYHA (New York Heart Association) functional class. | 30 days; 12 months. | NYHA functional class I, II, III, IV. |
| Change in degree of mitral regurgitation. | 30 days; 12 months. | Mitral regurgitation (MR) measured with echocardiography. The severity of MR graded as absent (0), mild (1), moderate (2), moderate-severe (3), or severe (4). |
| Change in NTproBNP. | Baseline; 12 months. | NTproBNP blood levels. |
| Hospitalization due to heart failure. | 12 months. | Hospitalization: patient hospitalization (yes/no). |
| QRS duration. | Baseline | QRS duration (milliseconds) measured with a 12-lead ECG (200mm/s). |
| Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire). | 30 days; 12 months. | Score in Kansas City Cardiomyopathy Questionnaire-12: (higher=better). |
| Correction of global longitudinal strain | 30 days; 12 months | Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography |
Countries
Spain
Contacts
CONTACTLluís Mont, MD, PhD
STUDY_DIRECTORLluís Mont, MD, PhD
Hospital Clínic de Barcelona. IDIBAPS
Outcome results
None listed