Leadless PacemakerVAMPIRENCT06455566
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
An observational study of Leadless Pacemaker and Same-day Discharge, run by University Hospital, Caen at 13 sites in France.
Trial summary
Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leadless Pacemaker, Same-day Discharge
- What is being tested?
- Leadless pacemaker implantation through right internal jugular vein
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 13 sitesFrance
- Study dates
- 1 May 2024to 1 May 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with a guideline-based pacemaker indication and eligible to leadless pacemaker implantation.
Who may be able to join
- Indication of pacemaker implantation
- Eligible to leadless pacemaker
Who cannot join
- Contraindication to right internal jugular vein access
- Age < 18 year-old
- Patient already included in a clinical study
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites
Angers University Hospital
Angers
Caen University Hospital
Caen
Grenoble University Hospital
Grenoble
Lille University Hospital
Lille
Lyon University Hospital
Lyon
Metz-Thionville Regional Hospital
Metz
Le Millénaire Private Hospital
Montpellier
Les Franciscaines Private Hospital
Nîmes
Rennes University Hospital
Rennes
La Réunion University Hospital
Saint Pierre de La Réunion
Strasbourg University Hospital
Strasbourg
Toulouse University Hospital
Toulouse
Tours University Hospital
Tours
About this study
Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). As a consequence, the need for prolonged in-hospital monitoring after LP implantation though the right femoral (RF)vein is a barrier to same-day discharge. Recently, right internal jugular (RIJ) vein access has emerged an alternative to right RF vein access for LP implantation (with a regulatory approval for MEDTRONIC Micra LP).
The aims of this registry are the following :
- evaluate the feasibility of RIJ access for LP implantation;
- confirm the acute and chronic safety of RIJ access for LP implantation;
- compare RIJ to RF (historical cohort) vein access regarding procedural characteristics and outcomes;
- evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein.
- Conditions
- Leadless Pacemaker, Same-day Discharge
- Being tested
- Leadless pacemaker implantation through right internal jugular vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadless pacemaker implantation through right internal jugular veinDevice
Leadless pacemaker implantation through right internal jugular vein
| Study group | Role | What they receive |
|---|---|---|
| Leadless pacemaker implantation through right internal jugular vein | Not described Receives: Device: Leadless pacemaker implantation through right internal jugular vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of effective of jugular access
Feasibility of jugular access for leadless pacemaker implantation, defined as the percentage of patients with a successful leadless pacemaker implantation through the jugular vein.
Measured: [0 - 1 Month]
Rate of effective same-day discharge
Feasibility of same-day discharge after implantation of a leadless pacemaker through the jugular vein, defined as a successful same-day discharge with no readmission during the first postoperative month.
Measured: [0 - 1 Month]
Incidence of major cardiovascular event
Incidence of major complications related to the implantation of a leadless through the jugular vein:
- pericardial complications (effusion, tamponade, pericardiocentesis)
- jugular venous complications (bleeding, hematoma, arteriovenous fistula, vascular surgery)
- carotid artery complications (bleeding, transient ischemic attack or stroke, vascular surgery)
- pacemaker malfunction
- infection
- cardiac rhythm complications (atrioventricular block, ventricular fibrillation ou tachycardia, cardiac arrest)
- air embolism
Measured: [0 - 12 Month]
Secondary outcomes (1)
Description of procedural characteristics
Procedural characteristics of leadless pacemaker implantation through the jugular vein (duration, position, number of attempts, ...).
Measured: During implantation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 May 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Leadless PacemakerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455566
- Sponsor's protocol ID
- RYTHMO-2024-01
- Acronym
- VAMPIRE
- Status last verified
- Feb 2025
- First submitted
- 3 Jun 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Chami MF, Garweg C, Clementy N, Al-Samadi F, Iacopino S, Martinez-Sande JL, Roberts PR, Tondo C, Johansen JB, Vinolas-Prat X, Cha YM, Grubman E, Bordachar P, Stromberg K, Fagan DH, Piccini JP. Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry. Eur Heart J. 2024 Apr 7;45(14):1241-1251. doi: 10.1093/eurheartj/ehae101.
PubMed 38426911Saleem-Talib S, van Driel VJ, Chaldoupi SM, Nikolic T, van Wessel H, Borleffs CJW, Ramanna H. Leadless pacing: Going for the jugular. Pacing Clin Electrophysiol. 2019 Apr;42(4):395-399. doi: 10.1111/pace.13607. Epub 2019 Feb 25.
PubMed 30653690Saleem-Talib S, van Driel VJ, Nikolic T, van Wessel H, Louman H, Borleffs CJW, van der Heijden J, Cox M, Ramanna H. The jugular approach for leadless pacing: A novel and safe alternative. Pacing Clin Electrophysiol. 2022 Oct;45(10):1248-1254. doi: 10.1111/pace.14587. Epub 2022 Sep 12.
PubMed 36031774
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
- ClinicalTrials.gov ID
- NCT06455566
- Acronym / sponsor ID
- VAMPIRE / RYTHMO-2024-01
- Conditions
- Leadless Pacemaker, Same-day Discharge
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). As a consequence, the need for prolonged in-hospital monitoring after LP implantation though the right femoral (RF)vein is a barrier to same-day discharge. Recently, right internal jugular (RIJ) vein access has emerged an alternative to right RF vein access for LP implantation (with a regulatory approval for MEDTRONIC Micra LP).
The aims of this registry are the following :
- evaluate the feasibility of RIJ access for LP implantation;
- confirm the acute and chronic safety of RIJ access for LP implantation;
- compare RIJ to RF (historical cohort) vein access regarding procedural characteristics and outcomes;
- evaluate the feasibility of same-day discharge avec LP implantation through the RIJ vein.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leadless pacemaker implantation through right internal jugular vein | – | Device: Leadless pacemaker implantation through right internal jugular vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with a guideline-based pacemaker indication and eligible to leadless pacemaker implantation.
Key inclusion criteria (2 listed)
- Indication of pacemaker implantation
- Eligible to leadless pacemaker
Key exclusion criteria (3 listed)
- Contraindication to right internal jugular vein access
- Age < 18 year-old
- Patient already included in a clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leadless pacemaker implantation through right internal jugular veinLeadless pacemaker implantation through right internal jugular vein | Device | Leadless pacemaker implantation through right internal jugular vein |
Primary outcome
Rate of effective of jugular access
Time frame: [0 - 1 Month]
Feasibility of jugular access for leadless pacemaker implantation, defined as the percentage of patients with a successful leadless pacemaker implantation through the jugular vein.
Rate of effective same-day discharge
Time frame: [0 - 1 Month]
Feasibility of same-day discharge after implantation of a leadless pacemaker through the jugular vein, defined as a successful same-day discharge with no readmission during the first postoperative month.
Incidence of major cardiovascular event
Time frame: [0 - 12 Month]
Incidence of major complications related to the implantation of a leadless through the jugular vein: * pericardial complications (effusion, tamponade, pericardiocentesis) * jugular venous complications (bleeding, hematoma, arteriovenous fistula, vascular surgery) * carotid artery complications (bleeding, transient ischemic attack or stroke, vascular surgery) * pacemaker malfunction * infection * cardiac rhythm complications (atrioventricular block, ventricular fibrillation ou tachycardia, cardiac arrest) * air embolism
1 secondary outcome
Description of procedural characteristics
Time frame: During implantation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Results publication: PubMed 38426911El-Chami MF, Garweg C, Clementy N, Al-Samadi F, Iacopino S, Martinez-Sande JL, Roberts PR, Tondo C, Johansen JB, Vinolas-Prat X, Cha YM, Grubman E, Bordachar P, Stromberg K, Fagan DH, Piccini JP. Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry. Eur Heart J. 2024 Apr 7;45(14):1241-1251. doi: 10.1093/eurheartj/ehae101.
- Results publication: PubMed 30653690Saleem-Talib S, van Driel VJ, Chaldoupi SM, Nikolic T, van Wessel H, Borleffs CJW, Ramanna H. Leadless pacing: Going for the jugular. Pacing Clin Electrophysiol. 2019 Apr;42(4):395-399. doi: 10.1111/pace.13607. Epub 2019 Feb 25.
- Results publication: PubMed 36031774Saleem-Talib S, van Driel VJ, Nikolic T, van Wessel H, Louman H, Borleffs CJW, van der Heijden J, Cox M, Ramanna H. The jugular approach for leadless pacing: A novel and safe alternative. Pacing Clin Electrophysiol. 2022 Oct;45(10):1248-1254. doi: 10.1111/pace.14587. Epub 2022 Sep 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leadless Pacemaker and Same-day Discharge, run by University Hospital, Caen at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of effective of jugular access (time frame: [0 - 1 Month]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06455566, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.