Micra Atrial TRacking Using A Ventricular AccELerometer 2

Atrioventricular Conduction Block Clinical Trial

— MARVEL2  

Official title:

Micra Atrial TRacking Using A Ventricular AccELerometer 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752151
• Other study ID #: MDT18024
• Status: Completed
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: August 7, 2019

Study information

• Verified date: May 2020
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 at approximately 15-20 centers in up to 100 subjects to obtain at least 70 usable Holter datasets to meet the objectives of the study. The expected total study duration (from first subject enrollment to the exit of the last subject) is approximately 6-months; this represents the time necessary to enroll the target sample size of at least 70 subjects with usable Holter datasets. Software will be downloaded into patients implanted with a Micra device to allow the new algorithm performance to be measured in patients where a Micra device has already been chosen as most appropriate for the patient.

Most enrolled subjects will complete the study procedures during a single study visit. However, subjects enrolling in the study at the time of their Micra implant (anticipated to be approximately 10 subjects) will have the investigational algorithm downloaded following Micra implant, prior to hospital discharge, and approximately 1-month post-implant. This subset of subjects with de novo Micra implants will allow the MARVEL 2 features to be tested at multiple points in the device life cycle.

Since the download algorithm running in a Micra device significantly increases current drain, a 2-4 hour acute study is used to limit the reduction in device longevity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 7, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrioventricular Block
• Atrioventricular Conduction Block

Intervention

Device:
• MARVEL 2 Algorithm Monitor Mode then Adaptive Mode
Software download into implanted Micra device and programmed to MARVEL 2 Monitor Mode then MARVEL 2 Adaptive Mode

Locations

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Ventricular Pacing Synchrony Success During Rest	A subject will meet the primary endpoint if a paced or sensed ventricular beat is within 300 ms following an ECG confirmed P-wave for at least 70% of the ECG confirmed P-waves. The primary endpoint will be evaluated during the MARVEL 2 setup phase during MARVEL 2 Algorithm monitor mode (VDI pacing which is effectively VVI pacing) and during the 20-minute resting period in which the MARVEL 2 Algorithm is programmed to Adaptive mode (VDD pacing)	40 Minutes
Primary	Number of Participants Free From Inappropriate Pacemaker Function Events	A participant will meet the primary endpoint if they are free from the following MARVEL 2 software related events during the entire Holter monitoring period where the MARVEL 2 features are enabled.; Inappropriate pacemaker function events are defined as: Cardiac pauses lasting longer than 2 cardiac cycles (where cardiac cycle length is defined by the programmed lower rate interval of the pacemaker), OR; Pacemaker oversensing induced tachycardia exceeding 3-minutes, defined as oversensing of the pacemaker's accelerometer signal leading to a heart rate exceeding 100 beats per minute.	Through study completion an average of one day
Secondary	Left Ventricular Outflow Tract Velocity Time Integral	The secondary endpoint is left ventricular outflow tract (LVOT) velocity time integral (VTI) as obtained from echocardiogram while the MARVEL 2 features are in adaptive mode (VDD pacing) and while the MARVEL 2 features are in monitor mode (VDI pacing which is effectively VVI pacing). This was measured by the echo core laboratory that was blinded to the study participant and MARVEL 2 algorithm mode.	12 cardiac cycles