National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS)

Pacemaker Clinical Trial

Official title:

France LEADLESS, Comprehensive Follow-up of the Leadless Stimulator AVEIR VR LP

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06262295
• Other study ID #: 2023-A02475-40
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: September 2027

Study information

• Verified date: February 2024
• Source: French Cardiology Society
• Contact: Pascal DEFAYE
• Phone: (0)4 76 76 50 48
• Email: PDefaye[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead. The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe. The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient implanted with an AVEIR VR LP device
• Patient over 18 years old
• Patient informed of the nature of the study, agrees to participate in the study

Exclusion Criteria:

• Patient under 18 years of age
• Patient refusing to participate in the study

Related Conditions & MeSH terms

• Pacemaker

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Abbott

References & Publications (5)

Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available. Erratum In: Eur Heart J. 2022 May 1;43(17):1651. — View Citation

Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014 May;35(18):1186-94. doi: 10.1093/eurheartj/eht511. Epub 2013 Dec 17. — View Citation

Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022. — View Citation

Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24. — View Citation

Udo EO, Zuithoff NP, van Hemel NM, de Cock CC, Hendriks T, Doevendans PA, Moons KG. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012 May;9(5):728-35. doi: 10.1016/j.hrthm.2011.12.014. Epub 2011 Dec 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To confirm the safety of the AVEIR VR LP device	Assessed by rate of successful implantation, absence of complications (as assessed by number of procedural or device related complications) and reoperation (as assessed by number of replacement, explantation, change in device position)	during 24 months after implantation
Primary	To confirm the effectiveness of the AVEIR VR LP device	device longevity and electrical performance as assessed by stimulation threshold, % stimulation, impedance and amplitudes of R waves in the zone therapeutic	during 24 months after implantation
Primary	To collect patient characteristics and indications in normal conditions of use of the AVEIR VR LP device	Exhaustive collection of all cases of patients implanted in all French centers accredited to implant leadless stimulators in France	during 24 months after implantation