Abbott Brady 3T MRI PMCF
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|ClinicalTrials.gov Identifier: NCT03786640|
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment|
|Syncope Presyncope Fatigue Disorientation Arrythmia Bradycardia||Radiation: 3T MRI scan|
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|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)|
|Actual Study Start Date :||October 4, 2019|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2024|
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.
- Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width [ Time Frame: from pre- MRI scan to one-month post MRI scan ]
- Proportion of subjects with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to one-month post-MRI scan [ Time Frame: from pre-MRI scan to one-month post-MRI scan ]
- Rate of MRI-related adverse events [ Time Frame: from pre- to 12-month post- MRI scan ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786640
|Contact: Huawen DINGfirstname.lastname@example.org|
|CHRU Hopital de Pontchaillou||Recruiting|
|Rennes, Brittany, France, 35033|
|Contact: Nathalie Behar email@example.com|
|Hopital Cardiovasculaire et Pneumologique Louis Pradel||Recruiting|
|Lyon, Rhone-alpes, France, 69394|
|Contact: Philippe Chevalier, Pr. firstname.lastname@example.org|
|AOU Federico II - Università degli Studi di Napoli||Recruiting|
|Napoli, Campania, Italy, 80138|
|Contact: Antonio Rapacciuolo email@example.com|