Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 MRIâ„¢ or Endurity MRIâ„¢ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of MRI-related adverse events | including but not limited to, the following:
| from pre- to 12-month post- MRI scan |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | 50406 | Estonia | |||
| Hopital Cardiovasculaire et Pneumologique Louis Pradel |
Not provided
| ID | Term |
|---|---|
| D013575 | Syncope |
| D005221 | Fatigue |
| D003221 | Confusion |
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
| Lyon |
| Auvergne-Rhône-Alpes |
| 69394 |
| France |
| CHRU Hopital de Pontchaillou | Rennes | Brittany Region | 35033 | France |
| Care Institute of Medical Sciences | Ahmedabad | Gurarat | 380060 | India |
| Eternal Haert Care Centre | Jaipur | Rajasthan | 302017 | India |
| Apollo Hospital | Chennai | Tamil Nadu | 600 006 | India |
| AOU Federico II - Università degli Studi di Napoli | Naples | Campania | 80138 | Italy |
| Medisch Centrum Leeuwarden | Leeuwarden | Provincie Friesland | 8934 AD | Netherlands |
| Albert Schweiter Ziekenhuis | Dordrecht | South Holland | 3318 AT | Netherlands |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |