Aortic Valve Stenosis Clinical Trial
— PLANETOfficial title:
Pacing of the Left Bundle Branch Area NEcessitated After TAVR
Verified date | January 2023 |
Source | Ludwig-Maximilians - University of Munich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | April 2025 |
Est. primary completion date | April 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis - LVEF =50% - Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden >20% - Signed informeed conseent to study participation Exclusion Criteria: - LVEF <50% - Expected pacing burden <20% - Pre-existing implanted cardiac device - Participation in a concurring interventional trial - age <18 years - Current preegnancy - life expectancy <6 months |
Country | Name | City | State |
---|---|---|---|
Germany | LMU Klinikum | Munich | BY |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pacemaker-associated complications | 3 months | ||
Other | Pacemaker-associated complications | 12 months | ||
Other | Pacemaker-associated complications | 24 months | ||
Other | procedural implantation success | dichotomous yes / no | basline | |
Other | Implantation procedure duration | baseline | ||
Other | Fluoroscopy duration | baseline | ||
Other | Fluoroscopy dose | baseline | ||
Primary | QRS duration | QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads | 3 months | |
Secondary | QRS duration | QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads | 12 months | |
Secondary | QRS duration | QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads | 24 months | |
Secondary | Death of any cause | 3 months | ||
Secondary | Death of any cause | 12 months | ||
Secondary | Death of any cause | 24 months | ||
Secondary | Death of cardio-vascular cause | 3 months | ||
Secondary | Death of cardio-vascular cause | 12 months | ||
Secondary | Death of cardio-vascular cause | 24 months | ||
Secondary | Re-hospitalization due to heart failure | 3 months | ||
Secondary | Re-hospitalization due to heart failure | 12 months | ||
Secondary | Re-hospitalization due to heart failure | 24 months | ||
Secondary | Change in left ventricular ejection fraction | 3 months | ||
Secondary | Change in left ventricular ejection fraction | 12 months | ||
Secondary | Change in left ventricular ejection fraction | 24 months | ||
Secondary | Change in echocardiographic left ventricular enddiastolic diameter | 3 months | ||
Secondary | Change in echocardiographic left ventricular enddiastolic diameter | 12 months | ||
Secondary | Change in echocardiographic left ventricular enddiastolic diameter | 24 months | ||
Secondary | Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency | 3 months | ||
Secondary | Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency | 12 months | ||
Secondary | Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency | 24 months | ||
Secondary | Echocardiographic assessment of right ventricular ejection fraction | 3 months | ||
Secondary | Echocardiographic assessment of right ventricular ejection fraction | 12 months | ||
Secondary | Echocardiographic assessment of right ventricular ejection fraction | 24 months | ||
Secondary | Change in New York heart failure classification status | 3 months | ||
Secondary | Change in New York heart failure classification status | 12 months | ||
Secondary | Change in New York heart failure classification status | 24 months | ||
Secondary | Change in laboratory biomarkers NT-proBNP | 3 months | ||
Secondary | Change in laboratory biomarkers NT-proBNP | 12 months | ||
Secondary | Change in laboratory biomarkers NT-proBNP | 24 months | ||
Secondary | Change in functional status by 6 minute walk | 3 months | ||
Secondary | Change in functional status by 6 minute walk | 12 months | ||
Secondary | Change in functional status by 6 minute walk | 24 months | ||
Secondary | Change in EQ-5D quality of life | 3 months | ||
Secondary | Change in EQ-5D quality of life | 12 months | ||
Secondary | Change in EQ-5D quality of life | 24 months | ||
Secondary | Occurence of arrhythmias | 3 months | ||
Secondary | Occurence of arrhythmias | 12 months | ||
Secondary | Occurence of arrhythmias | 24 months |
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