Defibrillator Clinical Trial
— FRAGILEOfficial title:
French Attitude Registry in Case of ICD Lead Replacement
| NCT number | NCT01829269 |
| Other study ID # | 12 759 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2013 |
| Est. completion date | May 2019 |
| Verified date | August 2019 |
| Source | French Cardiology Society |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years
and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher
complication rate than average. We will therefore be increasingly confronted with faulty
sensors or at risk to be replaced.
There are no standardized approach for replacing defibrillation lead. A record made in the
United States showed significant differences according to the teams strategy in case of
failure of defibrillation lead in particular with regard to the decision to explant or
abandon the probe.
The risk of extracting a defibrillation lead are well known with a major complication rate of
1.6 to 1.95%.
Regarding the risk of complications related to the abandonment of a probe we have less data.
For some there is no risk to abandon a defibrillation lead. But others reported a
complication rate of 5.5% related to pacing discontinued.
Main objective: Collect the attitude of different centers and different operators when
replacing a failed defibrillation lead or "at risk." Explantation or abandonment of the
sensor replaced.
| Status | Completed |
| Enrollment | 559 |
| Est. completion date | May 2019 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient to receive a replacement defibrillation lead not motivated by an infection and having been informed. - Patient who agreed to participate in the study - Patients aged 18 years and over No Exclusion Criteria |
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique Ambroise Paré | Neuilly Sur Seine |
| Lead Sponsor | Collaborator |
|---|---|
| French Cardiology Society |
France,
Glikson M, Suleiman M, Luria DM, Martin ML, Hodge DO, Shen WK, Bradley DJ, Munger TM, Rea RF, Hayes DL, Hammill SC, Friedman PA. Do abandoned leads pose risk to implantable cardioverter-defibrillator patients? Heart Rhythm. 2009 Jan;6(1):65-8. doi: 10.1016/j.hrthm.2008.10.012. Epub 2008 Oct 11. — View Citation
Goette A, Cantu F, van Erven L, Geelen P, Halimi F, Merino JL, Morgan JM; Scientific Initiative Committee of the European Heart Rhythm Association. Performance and survival of transvenous defibrillation leads: need for a European data registry. Europace. 2009 Jan;11(1):31-4. doi: 10.1093/europace/eun301. Epub 2008 Nov 11. — View Citation
Rickard J, Wilkoff BL. Extraction of implantable cardiac electronic devices. Curr Cardiol Rep. 2011 Oct;13(5):407-14. doi: 10.1007/s11886-011-0198-x. Review. — View Citation
Suga C, Hayes DL, Hyberger LK, Lloyd MA. Is there an adverse outcome from abandoned pacing leads? J Interv Card Electrophysiol. 2000 Oct;4(3):493-9. — View Citation
Wilkoff BL, Byrd CL, Love CJ, Hayes DL, Sellers TD, Schaerf R, Parsonnet V, Epstein LM, Sorrentino RA, Reiser C. Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol. 1999 May;33(6):1671-6. — View Citation
Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH 3rd, Epstein LM, Friedman RA, Kennergren CE, Mitkowski P, Schaerf RH, Wazni OM; Heart Rhythm Society; American Heart Association. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm. 2009 Jul;6(7):1085-104. doi: 10.1016/j.hrthm.2009.05.020. Epub 2009 May 22. — View Citation
Xu W, Moore HJ, Karasik PE, Franz MR, Singh SN, Fletcher RD. Management strategies when implanted cardioverter defibrillator leads fail: survey findings. Pacing Clin Electrophysiol. 2009 Sep;32(9):1130-41. doi: 10.1111/j.1540-8159.2009.02454.x. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Explanted probes | Percentage of explanted probes among implanted ones | 2 years | |
| Secondary | Complications of explantation | Percentage of events during and after explantation of probe | 2 years |
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