N/A
Completed N=77
Micra Atrial TRacking Using A Ventricular AccELerometer 2
Atrioventricular Conduction Block
Source: ClinicalTrials.gov NCT03752151 ↗
Enrolled (actual)
77
Serious AEs
4.0%
Results posted
Jun 2020
Primary outcomePrimary: Atrial Ventricular Pacing Synchrony Success During Rest — 0; 38; 0; 2 Participants — p=<0.001
Summary
The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal sinus node function and AV block
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atrial Ventricular Pacing Synchrony Success During Rest |
0; 38; 0; 2 | <0.001 sig |
| PRIMARY Number of Participants Free From Inappropriate Pacemaker Function Events |
75 | <0.001 sig |
| SECONDARY Left Ventricular Outflow Tract Velocity Time Integral |
1.7 | 0.002 sig |
Eligibility Criteria
Inclusion Criteria
- Subject has been implanted with a Micra TPS (Model MC1VR01) with remaining device longevity of 6 years or more or is expected to be implanted with a Micra TPS.
- Subject has history of AV block*
- Subject is ≥ 18 years old and as per required local law.
- Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
- Subject is willing and able to comply with the protocol. *This includes subjects with normal sinus function and persistent 3rd degree AV block and subjects with other forms of AV block.
Exclusion Criteria
- Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist.
- Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL 2 study procedures).
- Subject meets any exclusion criteria required by local law (age or other).
Data sourced from ClinicalTrials.gov (NCT03752151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.