Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI

NCT04482816 | Completed DMC

• 1 other identifier: PHYS-TAVI TRIAL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Implantation; Physiological Pacing; Right Ventricular Pacing; AV Block

Keywords

TAVI; Physiological Pacing; AV Block

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change in left ventricular ejection fraction.

  12 months

• Correction of echocardiographic asynchrony: septal flash expressed in mm.

  30 days; 12 months

• Distance covered in the 6-minute walking test.

  30 days; 12 months

• Change in NYHA functional class.

  30 days; 12 months

• Change in degree of mitral regurgitation.

  12 months

Study Arms (2)

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.

Device: Physiological pacing

Right ventricular pacing

ACTIVE COMPARATOR

Lead placed in the right ventricle (conventional pacing).

Device: Right ventricular pacing

Interventions

Physiological pacing DEVICE

Pacing of the his bundle or the left bundle branch

Physiological pacing

Right ventricular pacing DEVICE

Conventional pacing; right ventricular pacing

Right ventricular pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Josep Lluis Mont Girbau: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 41542133 DERIVED

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• José M Tolosana, MD, PhD

  Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

  PRINCIPAL INVESTIGATOR

• Margarida Pujol Lopez, MD

  Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

  PRINCIPAL INVESTIGATOR

• Lluís Mont, MD, PhD

  Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

  STUDY DIRECTOR

• Eduard Guasch, MD, PhD

  Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Arrhythmia Section. Professor of Cardiology

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 23, 2020
• Study Start: September 14, 2020
• Primary Completion: June 30, 2023
• Study Completion: October 30, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)