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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiological pacing | Experimental | 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. |
|
| Right ventricular pacing | Active Comparator | Lead placed in the right ventricle (conventional pacing). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiological pacing | Device | Pacing of the his bundle or the left bundle branch |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José M Tolosana, MD, PhD | Institut ClÃnic Cardiovascular (ICCV), Hospital ClÃnic Barcelona. | Principal Investigator |
| Margarida Pujol Lopez, MD | Institut ClÃnic Cardiovascular (ICCV), Hospital ClÃnic Barcelona. | Principal Investigator |
| LluÃs Mont, MD, PhD | Institut ClÃnic Cardiovascular (ICCV), Hospital ClÃnic Barcelona. | Study Director |
| Eduard Guasch, MD, PhD | Institut ClÃnic Cardiovascular (ICCV), Hospital ClÃnic Barcelona. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41542133 | Derived | Pujol-Lopez M, Regueiro A, Graterol FR, Garcia-Ribas C, Uribe L, Jimenez-Arjona R, Borras R, Guasch E, Guichard JB, Carballeira L, Falzone PV, Regany-Closa M, Casal R, Poza M, Arbelo E, Porta-Sanchez A, Roca-Luque I, Sitges M, Doltra A, Tolosana JM, Mont L. Left Bundle Branch Versus Apical Pacing in Atrioventricular Block and Normal Cardiac Function Post-transcatheter Aortic Valve Implantation: PhysTAVI Trial. CJC Open. 2025 Jul 30;7(12):1610-1620. doi: 10.1016/j.cjco.2025.07.014. eCollection 2025 Dec. |
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The patient will be explained to be randomized to either of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits, it will not be said which therapy has been applied.
The echocardiographer and the follow-up by the Hemodynamic Team will be blind.
| Right ventricular pacing |
| Device |
Conventional pacing; right ventricular pacing |
|
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 |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |