ImageReady(TM) MR Conditional Pacing System Clinical Study

Browse trials for

• Bradycardia 306
• Sick Sinus Syndrome 89

Keywords

• Single chamber pacing
• Dual chamber pacing
• MRI
• MR scans

Bradycardia

306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.

This study's enrollment of 363 is above the median of 99 across 174 interventional studies indexed under Bradycardia.

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Study arms

• Experimental
  MRI Group

  Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

  Radiation: MRI · Device: ImageReady System implant

• Experimental
  Control Group

  Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.

  Device: ImageReady System implant

Interventions

• RadiationMRI

  The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

  Also known as: MR Scan

• DeviceImageReady System implant

  Pacemaker and lead(s) implant

  Also known as: Single chamber pacemaker implant, Dual chamber pacemaker implant, Pace/ Sense pacemaker lead implant

Primary outcomes

1. Proportion of Participants Without MR Scan-related Complications

   The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.

   Time frame: MRI Visit + 1 Month

2. Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit

   The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up. Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups.

   Time frame: MRI + 1 Month Visit

3. Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit

   The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.

   Time frame: MRI + 1 Month Visit

Secondary outcomes

1. Proportion of Participants Without ImageReady System-related Complications

   Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.

   Time frame: 3 months post implant

Baseline characteristics