No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Pugazhendhi Vijayaraman · Other
Who this trial is looking for
This trial is looking for people who need a permanent pacemaker or defibrillator. Participants will help compare two methods for placing a wire in a specific part of the heart.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I need a permanent pacemaker or defibrillator with atrial pacing.
I am willing to follow all study procedures.
I will be available for the duration of the study.
You may not be able to join if
I cannot provide informed consent.
I am pregnant.
I am in another study that might affect this one.
I have persistent atrial fibrillation at the time of the procedure.
I have renal dysfunction with serum creatinine over 3.0 mg/dl.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
People eligible for this study are scheduled to have a permanent pacemaker (PPM) or defibrillator device (ICD) implanted as part of their routine care. This device will also have a wire placed in the right atrium (RA) of the heart. As an alternative to the RA, the wire can also be placed in the Bachmann bundle (BB).
This study is being done to compare two options to help place the wire in the Bac…
People eligible for this study are scheduled to have a permanent pacemaker (PPM) or defibrillator device (ICD) implanted as part of their routine care. This device will also have a wire placed in the right atrium (RA) of the heart. As an alternative to the RA, the wire can also be placed in the Bachmann bundle (BB).
This study is being done to compare two options to help place the wire in the Bachmann bundle. One option uses contrast dye and x-ray, and the other option uses electrocardiogram (ECG) and contrast dye and x-ray. We want to learn more about how well these options work in implanting the wire in the Bachmann bundle.
Both of these options are FDA approved and used in standard practice.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Patients \> 18 years of age
2. Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead
3. Patient is willing to comply with all study procedures and be available for the duration of the study.
Exclusion Criteria:
1. Inability to provide inform…
Inclusion Criteria:
1. Patients \> 18 years of age
2. Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead
3. Patient is willing to comply with all study procedures and be available for the duration of the study.
Exclusion Criteria:
1. Inability to provide informed consent
2. Pregnant
3. Enrolled in a concurrent study that may confound the results of this study.
4. Persistent atrial fibrillation at the time of implant (if cardioversion contraindicated at the time of implant, where BB mapping cannot be performed in sinus rhythm)
5. Renal dysfunction with serum Creatinine \>3.0 mg/dl
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