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Compares treatment options for Pacemaker Implantation
Official title Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
ClinicalTrials.gov ID: NCT06690333
What this study is testing
- What it's testing
- This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18
- Planned for:
- permanent pacemaker implantation for AV node disease (first, second or third degree), OR
- post-TAVR patient requiring permanent pacemaker implantation
- Preserved ejection fraction \> 50%
You likely can't join if
- Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation
- Anatomical restriction for either MICRA or transvenous pacing such as
- Access vein occlusion or thrombosis
- previous radiation therapy at insertion site
- inferior vena cava filter
- Endstage renal disease (ESRD)/on dialysis
See the full eligibility criteria
- Age \> 18
- Planned for:
- permanent pacemaker implantation for AV node disease (first, second or third degree), OR
- post-TAVR patient requiring permanent pacemaker implantation
- Preserved ejection fraction \> 50%
- Preserved sinus node function
- Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
- Life expectancy \> 1 year
- Female subject of childbearing potential is not pregnant, not breast feeding, does not plan to be pregnant during the course of the study, and agrees to use a highly effective contraceptive method (i.e. IUD, birth...
- Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB
- Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation
- Anatomical restriction for either MICRA or transvenous pacing such as
- Access vein occlusion or thrombosis
- previous radiation therapy at insertion site
- inferior vena cava filter
- Endstage renal disease (ESRD)/on dialysis
- Dementia (inability to give consent)
- Moderate to Severe or Severe Tricuspid valve regurgitation
- Moderate to Severe or Severe Mitral valve regurgitation
- History of mitral or tricuspid valve surgery
- Preexisting implanted pacemaker or ICD or lead
- Subject is allergic to titanium
- Life expectancy \< 1 year
- Recurrent or high risk of infections
- Active malignancy requiring systemic chemotherapy or local chest radiation
- Subject has myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit
- CABG, valve surgery or PCI within the last 3 months except TAVR
- Other major cardiac surgery within the last 6 months
- Persistent and permanent atrial fibrillation diagnosed by a healthcare provider
- NYHA class 3 or 4 Heart Failure Additional post-TAVR Exclusion Criteria:
- Evidence of renal injury (12 hours post-TAVR)
- Access site complication(s) post-TAVR
- Suspicion of stroke/cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 hours post-TAVR
- Physician suspicion that ambulation to pre-TAVR activities post-pacemaker implantation would be unattainable
- Other post-TAVR complications that in the opinion of the investigator may seriously confound study outcomes
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Florida, United States
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Florida, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.