Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)

Trial compares two heart pacing methods after TAVI valve replacement

NCT: NCT06197503 · Status: RECRUITING · Phase: N/A · Sponsor: Hospital Clinic of Barcelona · Started: 2023-11-30 · Est. Completion: 2026-12-15

Plain English Summary

Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI is a Not Applicable clinical trial sponsored by Hospital Clinic of Barcelona studying Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block, Preserved Left Ventricular Systolic Function. This study tests two different ways to pace the heart after a TAVI procedure, which replaces a heart valve. It is for patients who need a pacemaker after TAVI and have normal heart pumping function. Participation involves being randomly assigned to one of the two pacing methods and being followed for 12 months. Alternatives include standard pacing or no pacing if a pacemaker is not strictly needed. The trial aims to enroll 48 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients who have had a successful TAVI procedure and need a pacemaker due to a heart rhythm problem (AV block). Patients must have normal heart pumping function (LVEF > 50%). Patients with severe heart failure (LVEF < 50%) or a life expectancy less than 12 months cannot join. Patients currently in another treatment study or who had a specific type of TAVI (transapical) are also excluded. This trial is studying Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block, Preserved Left Ventricular Systolic Function, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if patients improve in terms of survival, heart function class, or walking ability after 12 months, indicating a better overall health status. The specific primary outcome measures are: 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it seeks to find a better way to pace the heart after TAVI, potentially improving patient outcomes and quality of life by avoiding the negative effects of traditional pacing This research targets Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block, Preserved Left Ventricular Systolic Function, where improved treatment options are needed.

Investor Insight

This trial addresses a specific complication after a common procedure, with potential to influence standard care and device selection, suggesting a focused market opportunity for improved pacing techn

Is This Trial Right for Me?

Ask your doctor if you need a pacemaker after TAVI and what type of pacing is best for you. Participation means you will be randomly assigned to one of two pacing groups and will have regular check-ups for a year. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06197503?

NCT06197503 is a Not Applicable INTERVENTIONAL study titled "Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI." It is currently recruiting and is sponsored by Hospital Clinic of Barcelona. The trial targets enrollment of 48 participants.

What conditions does NCT06197503 study?

This trial investigates treatments for Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block, Preserved Left Ventricular Systolic Function. The primary condition under study is Transcatheter Aortic Valve Implantation.

What treatments are being tested in NCT06197503?

The interventions being studied include: Conduction system pacing (PROCEDURE), Right ventricular pacing (PROCEDURE). Left bundle branch pacing or His bundle branch pacing

What does Not Applicable mean for NCT06197503?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06197503?

This trial is currently "Recruiting." It started on 2023-11-30. The estimated completion date is 2026-12-15.

Who is sponsoring NCT06197503?

NCT06197503 is sponsored by Hospital Clinic of Barcelona. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06197503?

The trial aims to enroll 48 participants. The trial is currently recruiting and accepting new participants.

How is NCT06197503 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06197503?

The primary outcome measures are: 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). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06197503 being conducted?

This trial is being conducted at 1 site, including Barcelona (Spain).

Where can I find official information about NCT06197503?

The official record for NCT06197503 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06197503. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06197503 testing in simple terms?

This study tests two different ways to pace the heart after a TAVI procedure, which replaces a heart valve. It is for patients who need a pacemaker after TAVI and have normal heart pumping function.

Why is this trial significant?

This trial matters because it seeks to find a better way to pace the heart after TAVI, potentially improving patient outcomes and quality of life by avoiding the negative effects of traditional pacing

What are the potential risks of participating in NCT06197503?

Risks include those associated with any pacemaker implantation, such as infection or bleeding. Potential side effects specific to the pacing methods will be monitored, including any impact on heart function or rhythm. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06197503?

Ask your doctor if you need a pacemaker after TAVI and what type of pacing is best for you. Participation means you will be randomly assigned to one of two pacing groups and will have regular check-ups for a year. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06197503 signal from an investment perspective?

This trial addresses a specific complication after a common procedure, with potential to influence standard care and device selection, suggesting a focused market opportunity for improved pacing techn This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves being randomly assigned to one of the two pacing methods and being followed for 12 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Transcatheter Aortic Valve Implantation Trials

View all Transcatheter Aortic Valve Implantation clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.