Abbott Brady 3T MRI PMCF

Long Term Follow-up of the Tendril STS and Isoflex Leads in Conjunction With the Assurity MRI™ and Endurity MRI™ Pacemakers Within the 3T MRI Environment (Brady 3T MRI PMCF)

The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.

Study Overview

• Status: Completed
• Conditions: Fatigue; Bradycardia; Syncope; Arrythmia; Presyncope; Disorientation
• Intervention / Treatment: Radiation: 3T MRI scan

Detailed Description

This prospective, non-randomized, observational study will be conducted at 35 centers worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Estonia
  • Tartu, Estonia, 50406
    • Tartu University Hospital
• France
  • Brittany
    • Rennes, Brittany, France, 35033
      • CHRU Hopital de Pontchaillou
  • Rhone-alpes
    • Lyon, Rhone-alpes, France, 69394
      • Hopital Cardiovasculaire et Pneumologique Louis Pradel
• India
  • Gurarat
    • Ahmedabad, Gurarat, India, 380060
      • Care Institute of Medical Sciences
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Eternal Haert Care Centre
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 006
      • Apollo Hospital
• Italy
  • Campania
    • Napoli, Campania, Italy, 80138
      • AOU Federico II - Università degli Studi di Napoli
• Netherlands
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934 AD
      • Medisch Centrum Leeuwarden
  • Zuid-Holland
    • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
      • Albert Schweiter Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with an SJM Tendril STS 2088 or Isoflex 1944/1948 lead, together with an Assurity MRI or Endurity MRI pacemaker, and who will undergo a 3T MRI scan are eligible to participate in this study. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any study procedures not considered standard of care.

Description

Inclusion Criteria:

1. Subject must be willing and able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable).
2. Subject must be implanted with a St. Jude Medical Tendril STS 2088 or Isoflex 1944/1948 lead, and Assurity MRI or Endurity MRI pacemaker.
3. Capture threshold is stable and < 2.5V @ 0.5ms at the time of enrollment.
4. Subject is clinically indicated for a 3T MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
5. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

1. The subject is currently participating in a clinical investigation that includes an active treatment arm that may confound the results of this study as determined by Abbott.
2. The subject is <18 years old (pediatric).
3. That subject has a life expectancy of less than 12 months due to any condition.
4. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
6. Any contraindication to MRI scan, including the presence of additional hardware (e.g. lead extenders, lead adapters, surgical staples, stents, dental braces, or abandoned leads).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Arm; Patients implanted with an SJM Tendril STS 2088 or Isoflex 1944/1948 lead, together with an Assurity MRI or Endurity MRI pacemaker, and who will undergo a 3T MRI scan are eligible to participate in this study.	Radiation: 3T MRI scan; A clinically indicated 3T MRI scan will be performed per standard procedures for the radiology department. Cardiac monitoring during the MRI scan is recommended to include Pulse Oximetry and/or ECG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width	from pre- MRI scan to one-month post MRI scan

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to one-month post-MRI scan	from pre-MRI scan to one-month post-MRI scan

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MRI-related adverse events	including but not limited to, the following: Device (pulse generator) heating resulting in tissue damage in the implant pocket, or patient pocket discomfort, or both.; Induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse, or all three.; Loss of pacing or capture in the MRI environment.	from pre- to 12-month post- MRI scan

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): December 18, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: 3 Tesla MRI
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Unconsciousness; Consciousness Disorders; Bradycardia; Syncope; Confusion
• Other Study ID Numbers: ABT-CIP-10266

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No