Micra Atrial TRacking Using A Ventricular AccELerometer 2

Completed · Not applicable

Conditions studied: Atrioventricular Conduction Block

In brief

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

Key facts

Study ID

NCT03752151

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

77

Starts

2019-01-22

Expected to finish

2019-08-07

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Baptist Medical Center Jacksonville — Jacksonville, Florida, United States
• Baptist Hospital — Miami, Florida, United States
• North Shore University Hospital- Northwell — Manhasset, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Kepler Universitätsklinikum Med Campus III — Linz, Austria
• UZ Leuven - Campus Gasthuisberg — Leuven, Belgium
• Odense Universitetshospital — Odense C, Denmark
• Hôpital Haut-Lévêque - CHU de Bordeaux — Pessac, France
• Prince of Wales Hospital — Hong Kong, Hong Kong
• Institut Jantung Negara — Kuala Lumpur, Malaysia
• Hospital Universitari Clínic de Barcelona — Barcelona, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.