Is NCT07118358 recruiting in Orlando, FL?

Yes, NCT07118358 is currently enrolling participants at its Orlando, FL location. This leadless pacemaker clinical trial is accepting qualified participants.

How do I join the leadless pacemaker clinical trial in Orlando?

To join this clinical trial in Orlando, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orlando clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Leadless Pacemaker Clinical Trial in Orlando, FL

About This Leadless Pacemaker Study in Orlando

The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according to applicable guidelines. An integrated atrioventricular synchrony sub-study (AVS) is specifically designed to evaluate the AVS performance of the LivIQ system.

Sponsor: Biotronik, Inc.

Who Can Participate

Inclusion Criteria

Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines

Age is greater than or equal to 18 years at time of consent

Able to understand the nature of the study and provide written informed consent

Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up

Exclusion Criteria

AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met

Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle

Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement

Intolerance of dexamethasone acetate

Other implanted devices that, in the judgement of the implanting physician, could interfere (mechanically or electrically) with the leadless pacemaker or with the implant procedure

Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body

Prior leadless pacemaker implant attempt

Existing transvenous or leadless pacemaker, transvenous or subcutaneous ICD, or CRT device or previous extraction in which transvenous leads (full or partial) were left in the heart Note: Exception given to use temporary transvenous pacemakers

CIED device extraction within the previous 72 hours or signs of active infection after CIED extraction Note: Patients with extraction due to potential systemic infection must have a blood culture. A blood culture is considered negative if there is no growth within 72 hours prior to the LivIQ implant.

Planned ICD or CRT device implant

Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment

Life expectancy of less than 12 months

Unable to tolerate an urgent sternotomy

Planned right-sided heart intervention within 30 days after implant Note: Exception given to AV nodal ablations when performed by an implanting investigator once early safety phase objectives are met

Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD)

Participation or plan to participate in any other potentially confounding investigational drug or device trial, or any other clinical trial that may interfere with this study's treatment or protocol during the duration of the study Note: Co-enrollment in concurrent trials is only allowed when documented prior approval is obtained from BIOTRONIK

Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans)

Pregnant or plan to become pregnant during the duration of the study AVS Sub-Study Inclusion Criteria: After consenting to the main study, patients potentially eligible for the AVS Sub-Study must meet these additional criteria:

Willing and able to perform the requested procedures for the AVS assessments

Current or history of AV block Note: This includes patients with any degree or type of AV block, irrespective of related symptoms and relevance of the AV block for the underlying pacemaker indication AVS Sub-Study Exclusion Criteria: After consenting to the main study, patients potentially eligible for the AVS Sub-Study must not meet the following criterion: 1\. Permanent AF

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT07118358) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Leadless Pacemaker Treatment Options in Orlando, FL

If you're searching for leadless pacemaker treatment options in Orlando, FL, this clinical trial (NCT07118358) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this clinical trial. You'll receive care from experienced leadless pacemaker specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all leadless pacemaker clinical trials near you to find additional studies recruiting in your area.

Leadless Pacemaker Clinical Trial in Orlando, FL

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