Multicenter Randomised Controlled Trial: Benefit of Intra-pocket Echo-guided Axillary Puncture Compared With Percutaneous Echo-guided Axillary Puncture and Cephalic Vein Dissection for the Primary Implantation of Intracardiac Electronic Devices.
Study to Compare Three Venous Access Methods for Implanting Electronic Devices
Plain English Summary
Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device is a Phase 3 clinical trial sponsored by Hospices Civils de Lyon studying Primary Implantation of an Intracardiac Electronic Device Indication. Tests three methods of venous access for implanting electronic devices in the heart. For patients needing a pacemaker or defibrillator. Participation involves a medical procedure and informed consent. Alternatives include cephalic vein dissection, subclavian vein puncture, and axillary puncture. The trial aims to enroll 900 participants.
Official Summary
The implantation of an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted. The procedure involves inserting one or more intra-cardiac leads using venous access. Navigation in the heart chambers is guided by fluoroscopy. Each lead is connected to a box that is placed under the skin in the deltopectoral groove. The venous vascular approach or venous access is a key stage. It can be time-consuming and a source of complications (haematoma, pneumothorax, nerve damage, catheter malfunction). There are several methods of vascular access: cephalic vein dissection, subclavian vein puncture guided by anatomical landmarks, axillary puncture guided by scopy (X-rays) or intraoperative ultrasound. The implantation of an intra-cardiac electronic device (ICD) (pacemaker or defibrillator) is a frequent procedure, and one whose incidence is on the rise in the field of cardiology. In France in 2016, 69042 pacemakers and 8174 defibrillators were implanted. The procedure involves inserting one or more intra-cardiac leads using venous access. Navigation in the heart chambers is guided by fluoroscopy. Each lead is connected to a box that is placed under the skin in the deltopectoral groove. The venous vascular approach or venous access is a key stage. It can be time-consuming and a source of complications (haematoma, pneumothorax, nerve damage, catheter malfunction). There are several methods of vascular access: cephalic vein dissection, subclavian vein puncture guided by anatomical landmarks, axillary puncture guided by scopy (X-rays) or intraoperative ultrasound. The most commonly used venous access for DEIC implantation in Europe today is cephalic vein dissection (60%). The subclavian vein is used in 21% of cases and the axillary vein in 19%. There is currently no recommendation as to which techni
Who Can Participate
Here is what you need to know about eligibility for this trial. Age ≥ 18 years, first pacemaker or defibrillator implantation, informed consent. Excludes pregnant women, those with prior venous access issues, and those under legal protection. Must be in France, with no prior conflicting research participation. No specific health requirements beyond age and condition. This trial is studying Primary Implantation of an Intracardiac Electronic Device Indication, so participants generally need a confirmed diagnosis.
What They're Measuring
Measures success rates and vascular access time, providing valuable insights for patient care and procedure optimization. The specific primary outcome measures are: Success rates of the three procedures (During the intervention). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to improve the safety and efficiency of implanting electronic devices in the heart, addressing a common and growing procedure in cardiology. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Primary Implantation of an Intracardiac Electronic Device Indication, where improved treatment options are needed.
Investor Insight
Larger market with increasing demand for cardiac devices, competitive landscape with no clear recommendation, high approval probability. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 900 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about your eligibility and the risks involved. Participation involves a medical procedure and informed consent. The trial is being conducted at 7 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 900 participants
Interventions
- PROCEDURE: Intervention 1: Cephalic vein dissection — After an incision in the deltopectoral groove and careful dissection of the superficial fatty layer, the cephalic vein is revealed and separated from its tissue attachments over a distance of approximately 2 centimetres before being cannulated in order to introduce the necessary guides. The electronic device will be fitted using the guides introduced in this way.
- PROCEDURE: Intervention 2 : Percutaneous echo-guided axillary route — A standard vascular linear ultrasound probe is placed in a single-use sterile sheath. The probe is brought into contact with the skin and we then perform a needle puncture of the vein under ultrasound control. Once the puncture or punctures have been successful, a guide is inserted into the vein and the incision is made after the puncture. The electronic device will be fitted using the guides introduced in this way.
- PROCEDURE: Intervention 3 : Intrapocket ultrasound-guided axillary route — A special ultrasound probe (shaped like a hiccup) is placed in a single-use sterile sheath. After making an incision in the deltopectoral groove and dissecting the fatty layer, the probe is placed in contact with the pectoral muscle to visualise the axillary vein. Needle puncture of the vein is performed under ultrasound guidance. Once the puncture is successful, a guide is inserted into the vein. The electronic device will be fitted using the guides introduced in this way.
Primary Outcomes
- Success rates of the three procedures (During the intervention)
Secondary Outcomes
- Vascular access time (During the intervention)
Full Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * First implantation of a pacemaker or defibrillator (single or double chamber) or implantation of a lead in the left branch area in the case of a venticular lead. * Informed consent signed by the patient Exclusion Criteria: * Implantation of an intra-cardiac triple-chamber electronic device (cardiac resynchronisation) * Prior impossibility of venous access * Pregnant, parturient or breast-feeding women * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care * Persons admitted to a health or social establishment for purposes other than research * Adults under legal protection (guardianship, curatorship) * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme * Patients participating in other research that may interfere with this study
Trial Locations
- CHU Clermont-Ferrand, Clermont-Ferrand, France
- Hôpital F. MITTERRAND, Dijon, France
- Lyon-Croix Rousse, Lyon, France
- Lyon-Louis Pradel, Lyon, France
- Hôpital privé Jacques Cartier, Massy, France
- CH Annexy-Genevois, site Annecy, Metz, France
- CHU de Saint Etienne - Hôpital Nord, Saint-Priest-en-Jarez, France
Frequently Asked Questions
What is clinical trial NCT07273929?
NCT07273929 is a Phase 3 INTERVENTIONAL study titled "Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device." It is currently not yet recruiting and is sponsored by Hospices Civils de Lyon. The trial targets enrollment of 900 participants.
What conditions does NCT07273929 study?
This trial investigates treatments for Primary Implantation of an Intracardiac Electronic Device Indication. The primary condition under study is Primary Implantation of an Intracardiac Electronic Device Indication.
What treatments are being tested in NCT07273929?
The interventions being studied include: Intervention 1: Cephalic vein dissection (PROCEDURE), Intervention 2 : Percutaneous echo-guided axillary route (PROCEDURE), Intervention 3 : Intrapocket ultrasound-guided axillary route (PROCEDURE). After an incision in the deltopectoral groove and careful dissection of the superficial fatty layer, the cephalic vein is revealed and separated from its tissue attachments over a distance of approximately 2 centimetres before being cannulated in order to introduce the necessary guides. The electronic device will be fitted using the guides introduced in this way.
What does Phase 3 mean for NCT07273929?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07273929?
This trial is currently "Not Yet Recruiting." It started on 2026-09-01. The estimated completion date is 2028-02-01.
Who is sponsoring NCT07273929?
NCT07273929 is sponsored by Hospices Civils de Lyon. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07273929?
The trial aims to enroll 900 participants. The trial has not yet started recruiting.
How is NCT07273929 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07273929?
The primary outcome measures are: Success rates of the three procedures (During the intervention). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07273929 being conducted?
This trial is being conducted at 7 sites, including Clermont-Ferrand; Dijon; Lyon; Massy and 3 more sites (France).
Where can I find official information about NCT07273929?
The official record for NCT07273929 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07273929. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07273929 testing in simple terms?
Tests three methods of venous access for implanting electronic devices in the heart. For patients needing a pacemaker or defibrillator.
Why is this trial significant?
This trial aims to improve the safety and efficiency of implanting electronic devices in the heart, addressing a common and growing procedure in cardiology. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07273929?
Potential risks include hematoma, pneumothorax, nerve damage, and catheter malfunction. Side effects are minimal but may include pain and bruising at the puncture site. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07273929?
Ask your doctor about your eligibility and the risks involved. Participation involves a medical procedure and informed consent. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07273929 signal from an investment perspective?
Larger market with increasing demand for cardiac devices, competitive landscape with no clear recommendation, high approval probability. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves a medical procedure and informed consent. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.