Micra Atrial TRacking Using A Ventricular AccELerometer 2

Not Applicable

Completed

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 pacing in patients with normal sinus node function and AV block

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 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 & 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).

Arm && Interventions

Group	Intervention	Description
MARVEL 2 Algorithm Monitor Mode, Then MARVEL 2 Adaptive Mode	MARVEL 2 Algorithm Monitor Mode then Adaptive Mode	Participants first received MARVEL 2 algorithm monitor mode which provides standard VVI pacing for approximately 20 minutes followed by MARVEL 2 algorithm adaptive mode for approximately 2 hours which provides VDD pacing.

Primary Outcome Measures

Name	Time	Method
Atrial Ventricular Pacing Synchrony Success During Rest	40 Minutes	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)
Number of Participants Free From Inappropriate Pacemaker Function Events	Through study completion an average of one day	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: 1. Cardiac pauses lasting longer than 2 cardiac cycles (where cardiac cycle length is defined by the programmed lower rate interval of the pacemaker), OR 2. 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.

Secondary Outcome Measures

Name	Time	Method
Left Ventricular Outflow Tract Velocity Time Integral	12 cardiac cycles	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.

Locations (12): UZ Leuven - Campus Gasthuisberg
🇧🇪
Leuven, Belgium
Institut Jantung Negara
🇲🇾
Kuala Lumpur, Malaysia
Baptist Hospital
🇺🇸
Miami, Florida, United States
Baptist Medical Center Jacksonville
🇺🇸
Jacksonville, Florida, United States
North Shore University Hospital- Northwell
🇺🇸
Manhasset, New York, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
NYU Langone Medical Center
🇺🇸
New York, New York, United States
Kepler Universitätsklinikum Med Campus III
🇦🇹
Linz, Austria
Odense Universitetshospital
🇩🇰
Odense C, Denmark
Hôpital Haut-Lévêque - CHU de Bordeaux
🇫🇷
Pessac, France
Hospital Universitari Clínic de Barcelona
🇪🇸
Barcelona, Spain
Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong