Comparing two pacing methods after heart valve surgery
Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)
This study is testing whether a new way of pacing the heart after valve surgery can help patients feel better and have better heart function compared to a standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06197503 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of physiological pacing versus right ventricular pacing in patients who have undergone transcatheter aortic valve implantation (TAVI) and have preserved left ventricular function. It aims to determine which pacing strategy leads to better clinical outcomes and echocardiographic parameters over a 12-month period. The study will include 24 patients with AV block and will assess various health metrics, including survival rates, quality of life, and heart function. Participants will be randomly assigned to one of the two pacing methods to evaluate their effectiveness.
Who should consider this trial
Good fit: Ideal candidates are patients with AV block who have undergone successful TAVI and have a left ventricular ejection fraction greater than 50%.
Not a fit: Patients with ventricular dysfunction, those undergoing transapical TAVI, or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the optimal pacing strategy for patients post-TAVI, potentially improving their quality of life and clinical outcomes.
How similar studies have performed: While this approach is exploratory, similar studies have shown promising results in optimizing pacing strategies in cardiac patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Lluís Mont, MD, PhD
- Email: lmont@clinic.cat
- Phone: 93 2271778 Ext. 2094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.