Abbott Brady 3T MRI PMCF

NCT03786640 | Completed

• 1 other identifier: ABT-CIP-10266
• Study Type: observational
• Target: 3
• Locations: 5 countries
• Sites: 9

Brief Summary

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.

Conditions

Syncope; Presyncope; Fatigue; Disorientation; Arrythmia; Bradycardia

Keywords

3 Tesla MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (1)

• Rate of MRI-related adverse events

  from pre- to 12-month post- MRI scan

Study Arms (1)

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

Interventions

3T MRI scan RADIATION

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject must be willing and able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable).
• Subject must be implanted with a St. Jude Medical Tendril STS 2088 or Isoflex 1944/1948 lead, and Assurity MRI or Endurity MRI pacemaker.
• Capture threshold is stable and \< 2.5V @ 0.5ms at the time of enrollment.
• 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
• Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

You may not qualify if:

• 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.
• The subject is \<18 years old (pediatric).
• That subject has a life expectancy of less than 12 months due to any condition.
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
• 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.
• 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).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (9)

Tartu University Hospital

Tartu, 50406, Estonia

Location

Hopital Cardiovasculaire et Pneumologique Louis Pradel

Lyon, Auvergne-Rhône-Alpes, 69394, France

Location

CHRU Hopital de Pontchaillou

Rennes, Brittany Region, 35033, France

Location

Care Institute of Medical Sciences

Ahmedabad, Gurarat, 380060, India

Location

Eternal Haert Care Centre

Jaipur, Rajasthan, 302017, India

Location

Apollo Hospital

Chennai, Tamil Nadu, 600 006, India

Location

AOU Federico II - Università degli Studi di Napoli

Napoli, Campania, 80138, Italy

Location

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

Albert Schweiter Ziekenhuis

Dordrecht, South Holland, 3318 AT, Netherlands

Location

MeSH Terms

Conditions

Syncope; Fatigue; Confusion; Arrhythmias, Cardiac; Bradycardia

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: October 4, 2019
• Primary Completion: November 18, 2021
• Study Completion: December 18, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

IN (3); IT (1); NL (2); ES (1); FR (2)