Heart Disease Trial, Recruiting NCT07217392 Sponsor: Abbott Medical Devices Condition: Heart Disease
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Heart Disease Trial, Recruiting

NCT07217392
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who meet current medical guidelines for receiving one of two specific heart leads (Tendril STS 2088TC or UltiPace LPA1231) placed in a particular area of the heart called the Left Bundle Branch Area (confirm with trial site).
  • People who are 18 years of age or older, or who have reached the legal age of consent, whichever is higher.
  • People who are willing to follow the trial procedures and attend all required follow-up visits, tests, and appointments.
  • People who have been fully informed about the trial, agree to its conditions, and have signed a written consent form approved by an ethics review board.

Who may not be able to join:

  • People who have a heart condition that makes placing a lead unsafe, including a condition called tricuspid atresia, a mechanical tricuspid heart valve, or an expected sensitivity to a specific medication (dexamethasone sodium phosphate) used during the procedure.
  • People who already have a pacemaker, ICD, or similar implanted heart device.
  • People who have previously had an unsuccessful attempt to place a lead in the Left Bundle Branch Area of the heart.
  • People who have planned heart surgery or a heart-related procedure scheduled within 3 months after the implant.
  • People who are expected to need a heart transplant within 6 months.
  • People whose life expectancy is less than 6 months.
  • People who have another serious, life-threatening illness that is separate from their heart condition.
  • People who are already enrolled in, or planning to join, another clinical trial that could affect the results of this study.
  • People who are pregnant, nursing, or planning to become pregnant during the trial's follow-up period.
  • People who have other health, physical, social, or psychological conditions that, in the opinion of the trial doctor, could make it difficult to participate in or complete the trial requirements.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +17472450158

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Abbott Medical Devices
Registry
ClinicalTrials.gov
Start date
24 July 2025
Est. completion
30 April 2027

Where this trial is recruiting

🇧🇷 Brazil 🇫🇷 France 🇩🇪 Germany 🇮🇳 India 🇲🇾 Malaysia 🇸🇬 Singapore 🇪🇸 Spain

Primary endpoints

Infection Rate; Perforation Rate; Malfunction Rate; Cardiovascular Injury Rate; Implant success rate; Lead dislodgement rate; Pacing threshold; Impedence; Sensing Amplitude

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov