Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MARVEL algorithm · 1 trial · 1 indication
On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave.
Characterize the rate of atrioventricular synchrony provided by the MARVEL algorithm and compare the accelerometer signal amplitudes and the AV synchrony provided by the MARVEL algorithm with the data collected during the initial MARVEL procedure.
| Arm | Type | Description |
|---|---|---|
| Enrolled | EXPERIMENTAL | Subjects enrolled in the MARVEL study. Enrolled subjects will have the MARVEL algorithm downloaded into their implanted market released Micra device. |
| Name | Type | Description |
|---|---|---|
| MARVEL algorithm | DEVICE | Software download into implanted Micra device |
Inclusion Criteria: * Subject has been implanted with, or is expected to be implanted with a MicraTM TPS (Model MC1VR01), with remaining device longevity of 6 years or more. * Subject is ≥ 18 years old and as per required local law. * Subject has atrioventricular (AV) block. * Subject (and/or witne...
The MARVEL algorithm is used for Atrioventricular Conduction Block, a condition affecting the heart's electrical signaling. It is designed to address this cardiac conduction disorder. The algorithm is currently in clinical development, with a completed Phase 1 study evaluating its application in this indication.
The MARVEL algorithm is developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker RYTM. The company is conducting clinical research on this algorithm for the treatment of Atrioventricular Conduction Block.
The MARVEL algorithm is in Phase 1 of clinical development. It is an investigational product, not yet approved by regulatory authorities. One Phase 1 trial has been completed, and the algorithm remains under evaluation for Atrioventricular Conduction Block.
The MARVEL algorithm has one completed clinical trial, NCT03157297, titled 'Micra Atrial Tracking Using a Ventricular Accelerometer Study.' This Phase 1 study enrolled 70 participants with Atrioventricular Conduction Block across multiple countries, including the United States, Austria, Belgium, Czechia, Denmark, France, Italy, Malaysia, and Spain.
The MARVEL algorithm is not the same as the Micra Atrial Tracking study; rather, it is the subject of that study. The trial NCT03157297, titled 'Micra Atrial Tracking Using a Ventricular Accelerometer Study,' evaluates the MARVEL algorithm in patients with Atrioventricular Conduction Block.