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New treatment option for Severe Aortic Valve Stenosis
Official title Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
ClinicalTrials.gov ID: NCT07456280
What this study is testing
- What it's testing
- Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All must be met
- Age ≥ 18 years and
- Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and
- Presence of at least one of the following conduction disorders and
- Pre-procedural basal conduction disorder (e.g., right/left bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec.
You likely can't join if
- No exclusion criteria must be met
- Immediate indication for permanent pacemaker following the procedure.
- Persistent complete atrioventricular block.
- QRS \>160 msec and/or PR prolongation.
- Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge.
- Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system.
See the full eligibility criteria
- All must be met
- Age ≥ 18 years and
- Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and
- Presence of at least one of the following conduction disorders and
- Pre-procedural basal conduction disorder (e.g., right/left bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec.
- De novo conduction disorder after TAVI (de novo bundle branch block) with QRS between 120-160 msec.
- Clinical stability at 24 hours post-procedure and
- Capacity to give informed consent.
- No exclusion criteria must be met
- Immediate indication for permanent pacemaker following the procedure.
- Persistent complete atrioventricular block.
- QRS \>160 msec and/or PR prolongation.
- Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge.
- Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system.
- Life expectancy \< 12 months due to non-cardiovascular comorbidity.
- Refusal or inability to undergo outpatient follow-up.
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.