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AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes.
The primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right ventricular pacing | Active Comparator |
| |
| Left bundle branch area pacing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV pacing | Procedure | RV apical pacemaker implantation prior to AV node ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients developing pacemaker-induced cardiomyopathy | Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of < 50% | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular function | Left ventricular ejection fraction (%) | 36 months |
| Left Ventricular Global Longitudinal Strain | Global longitudinal strain of the left ventricle (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelisches Krankenhaus Hagen-Haspe | Not yet recruiting | Hagen | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| LBBA pacing | Procedure | LBBA pacemaker implantation prior to AV node ablation |
|
| 36 months |
| Right ventricular function | Tricuspid Annular Plane Systolic Excursion (mm) | 36 months |
| Right ventricular function | Right Ventricle - Pulmonary Artery Coupling (mm/mmHg) | 36 months |
| Right ventricular function | Right ventricular strain (%) | 36 months |
| NT-proBNP serum concentration (ng/L) | NT-proBNP serum concentration (ng/L) | 36 months |
| Quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score | Ranging from 0 to 100 with higher scores represent a better outcome. | 36 months |
| 6-minute walk distance (meters) | 36 months |
| All-cause mortality | 36 months |
| Number of patients with a rehospitalization due to heart failure/cardiac decompensation | 36 months |
| Number of patients with a rehospitalization due to pacemaker malfunction | 36 months |
| Number of patients with a rehospitalization due to atrial arrhythmia | 36 months |
| Number of patients experiencing a stroke or transient ischemic attack | 36 months |
| Procedure-related complications | Number of patients with one of the following events: death, stroke and TIA; clinically relevant bleeding (Bleeding Academic Research Consortium ≥2) including hematoma at the pacemaker pocket prolonging hospital stay; thrombosis of subclavian/axillary/cubital vein; pneumothorax, pericardial effusion and tamponade; myocardial or septal perforation; coronary vessel injury, including fistula formation; pacemaker lead dislocation or perforation; infection, including pacemaker pocket infection, lead infection, and pacemaker-associated endocarditis; treatment-requiring groin complications such as aneurysm, AV fistula, or dissection (prolonging hospital stay) | 36 months |
| St. Josefs-Hospital Wiesbaden GmbH | Recruiting | Wiesbaden | Germany |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |