Micra Atrial Tracking Using a Ventricular Accelerometer Study

Atrioventricular Conduction Block Clinical Trial

— MARVEL  

Official title:

Micra Atrial Tracking Using a Ventricular Accelerometer Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157297
• Other study ID #: MDT16064
• Status: Completed
• Phase: Phase 1
• Start date: July 10, 2017
• Est. completion date: November 24, 2017

Study information

• Verified date: October 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.

A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 24, 2017
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Exclusion Criteria:

• Subject is in atrial arrhythmia at the time of enrollment.

• 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 study manager.

• Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL study procedures).

• Subject meets any exclusion criteria required by local law (age or other).

Additional criteria for the MARVEL Evolve Sub-study:

Inclusion criteria:

• Subjects in the MARVEL Sub-Study have previously been enrolled in the MARVEL main study

Related Conditions & MeSH terms

• Atrioventricular Block
• Atrioventricular Conduction Block
• Heart Block

Intervention

Device:
• MARVEL algorithm
Software download into implanted Micra device

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum Med Campus III	Linz
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven
Czechia	Nemocnice Na Homolce	Praha 5	Czech Republic
Denmark	Odense Universitetshospital	Odense C
France	Hôpital Haut-Lévêque - CHU de Bordeaux	Pessac
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Italy	Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello	Pisa
Malaysia	Institut Jantung Negara	Kuala Lumpur
Spain	Hospital Universitari Clínic de Barcelona	Barcelona
United States	Emory University Hospital	Atlanta	Georgia
United States	Baptist Medical Center Jacksonville	Jacksonville	Florida
United States	Baptist Hospital	Miami	Florida
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  Denmark,  France,  Italy,  Malaysia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrioventricular synchrony	On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave.	Initial 24 hour period after patient enrollment
Primary	MARVEL Evolve Substudy	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.	Initial 24 hour period after patient enrollment