Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- AV Block
- Physiological Pacing
- Right Ventricular Pacing
- Transcatheter Aortic Valve Implantation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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. physiologic...
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.
Tracking Information
- NCT #
- NCT04482816
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: 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. Study Director: Lluís Mont, MD, PhD Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona. Study Chair: Eduard Guasch, MD, PhD Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
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