BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S

Description

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). 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.

Conditions

Sinus Node Dysfunction, Bradycardia, Atrioventricular Block

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Study Overview

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Study Details

Study overview

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). 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.

BIOTRONIK Conduction System Pacing With the Solia Lead

BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S

Condition
Sinus Node Dysfunction
Intervention / Treatment

-

Contacts and Locations

New York

NYU Heart Rhythm Center, New York, New York, United States, 10016

Paoli

Cardiology Consultants of Philadelphia, Paoli, Pennsylvania, United States, 19301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.
  • * Patient has an implant planned to utilize left bundle branch area (LBBA) 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
  • * Patient meets a standard contraindication for pacemaker system implant
  • * Patient is currently implanted with a pacemaker or ICD device
  • * Patient has had a previous unsuccessful attempt to place a lead in the LBBA
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Biotronik, Inc.,

Study Record Dates

2026-06