Status:
COMPLETED
Micra Atrial TRacking Using A Ventricular AccELerometer 2
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Atrioventricular Conduction Block
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pacin...
Detailed Description
The MARVEL 2 study is an acute, prospective, global, multi-center, software-download clinical study. The study is planned to be conducted in US, Europe, and Asia. The study is expected to be conducted...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2019
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03752151
Start Date
January 22 2019
End Date
August 7 2019
Last Update
June 4 2020
Active Locations (12)
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1
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States, 32207
2
Baptist Hospital
Miami, Florida, United States, 33176
3
North Shore University Hospital- Northwell
Manhasset, New York, United States, 11030
4
NYU Langone Medical Center
New York, New York, United States, 10016