BIOTRONIK Conduction System Pacing With the Solia Lead (NCT05251363) | Clinical Trial Compass
CompletedNot Applicable
BIOTRONIK Conduction System Pacing With the Solia Lead
United States194 participantsStarted 2022-12-12
Plain-language summary
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area. Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and Cardiac Resynchronization Therapy with a Pacemaker (CRT-P) systems are allowed.
* Patient has an implant planned to utilize left bundle branch area pacing within 30 days of consent
* Patient is able to understand the nature of the study and provide written informed consent
* Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
* Patient accepts Home Monitoring® concept
* Patient age is greater than or equal to 18 years at time of consent
Exclusion Criteria:
* Patient meets a standard contraindication for pacemaker system implant
* Patient is currently implanted with a pacemaker or Implantable Cardioverter-Defibrillator (ICD) device
* Patient has had a previous unsuccessful attempt to place a lead in the LBB area
* Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
* Patient is expected to receive a heart transplant within 12 months
* Patient life expectancy less than 12 months
* Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
* Patient reports pregnancy at the time of enrollment
* Patient is enrolled in any other investigational cardiac clinical study during the course of the study
What they're measuring
1
Serious Adverse Device Effect (SADE)-Free Rate at 3 Months
Timeframe: 3 months post implant
2
Implant Success Rate of the Solia S Lead in LBB Area