Abbott Brady 3T MRI PMCF

Fatigue Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786640
• Other study ID #: ABT-CIP-10266
• Status: Completed
• Start date: October 4, 2019
• Est. completion date: December 18, 2021

Study information

• Verified date: April 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arrythmia
• Bradycardia
• Confusion
• Disorientation
• Fatigue
• Presyncope
• Syncope

Intervention

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.

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu
France	Hopital Cardiovasculaire et Pneumologique Louis Pradel	Lyon	Rhone-alpes
France	CHRU Hopital de Pontchaillou	Rennes	Brittany
India	Care Institute of Medical Sciences	Ahmedabad	Gurarat
India	Apollo Hospital	Chennai	Tamil Nadu
India	Eternal Haert Care Centre	Jaipur	Rajasthan
Italy	AOU Federico II - Università degli Studi di Napoli	Napoli	Campania
Netherlands	Albert Schweiter Ziekenhuis	Dordrecht	Zuid-Holland
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Estonia,  France,  India,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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