Abbott Brady 3T MRI PMCF
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03786640|
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : April 14, 2022
|Condition or disease||Intervention/treatment|
|Syncope Presyncope Fatigue Disorientation Arrythmia Bradycardia||Radiation: 3T MRI scan|
|Study Type :||Observational|
|Actual Enrollment :||3 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|
|Actual Primary Completion Date :||November 18, 2021|
|Actual Study Completion Date :||December 18, 2021|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786640
|Tartu University Hospital|
|Tartu, Estonia, 50406|
|CHRU Hopital de Pontchaillou|
|Rennes, Brittany, France, 35033|
|Hopital Cardiovasculaire et Pneumologique Louis Pradel|
|Lyon, Rhone-alpes, France, 69394|
|Care Institute of Medical Sciences|
|Ahmedabad, Gurarat, India, 380060|
|Eternal Haert Care Centre|
|Jaipur, Rajasthan, India, 302017|
|Chennai, Tamil Nadu, India, 600 006|
|AOU Federico II - Università degli Studi di Napoli|
|Napoli, Campania, Italy, 80138|
|Medisch Centrum Leeuwarden|
|Leeuwarden, Friesland, Netherlands, 8934 AD|
|Albert Schweiter Ziekenhuis|
|Dordrecht, Zuid-Holland, Netherlands, 3318 AT|