Reveal In-Office Implants

Arrhythmias, Cardiac Clinical Trial

Official title:

Reveal® In-Office Implants Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168427
• Other study ID #: Reveal In-Office Implants
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: January 30, 2018
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: January 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (EP) laboratory setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is indicated for continuous arrhythmia monitoring with an Insertable Cardiac Monitor (ICM)

• Patient is willing to undergo implant in clinic setting with only local anesthetic and/or oral anti-anxiety medications for sedation

• Patient is 18 years of age or older

• Patient is willing and able to provide consent and authorize the use and disclosure of health information

• Patient is willing and able to comply with the protocol including the required follow-up

Exclusion Criteria:

• Patient has reduced immune function or is otherwise at high risk for infection

• Patient has had a recent (within 30 days) or otherwise unresolved infection

• Patient is implanted or indicated for implant with a pacemaker, Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or hemodynamic monitoring system

• Patient is participating in another clinical study that may have an impact on the study endpoints

• Patient's life expectancy is less than 1 year

• Patient is pregnant

• Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Device:
• Reveal® DX or Reveal® XT Insertable Cardiac Monitor
Reveal® DX and Reveal® XT Insertable Cardiac Monitors are implantable patient-activated and automatically-activated monitoring systems that record subcutaneous ECG.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

References & Publications (27)

Al-Khatib SM, Lucas FL, Jollis JG, Malenka DJ, Wennberg DE. The relation between patients' outcomes and the volume of cardioverter-defibrillator implantation procedures performed by physicians treating Medicare beneficiaries. J Am Coll Cardiol. 2005 Oct 18;46(8):1536-40. Epub 2005 Sep 23. Erratum in: J Am Coll Cardiol. 2005 Nov 15;46(10):1964. — View Citation

Armstrong VL, Lawson J, Kamper AM, Newton J, Kenny RA. The use of an implantable loop recorder in the investigation of unexplained syncope in older people. Age Ageing. 2003 Mar;32(2):185-8. — View Citation

Brignole M, Menozzi C, Moya A, Garcia-Civera R, Mont L, Alvarez M, Errazquin F, Beiras J, Bottoni N, Donateo P; International Study on Syncope of Uncertain Etiology (ISSUE) Investigators. Mechanism of syncope in patients with bundle branch block and negative electrophysiological test. Circulation. 2001 Oct 23;104(17):2045-50. — View Citation

Brignole M, Sutton R, Menozzi C, Garcia-Civera R, Moya A, Wieling W, Andresen D, Benditt DG, Vardas P; International Study on Syncope of Uncertain Etiology 2 (ISSUE 2) Group. Early application of an implantable loop recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope. Eur Heart J. 2006 May;27(9):1085-92. Epub 2006 Mar 28. — View Citation

Chamis AL, Peterson GE, Cabell CH, Corey GR, Sorrentino RA, Greenfield RA, Ryan T, Reller LB, Fowler VG Jr. Staphylococcus aureus bacteremia in patients with permanent pacemakers or implantable cardioverter-defibrillators. Circulation. 2001 Aug 28;104(9):1029-33. — View Citation

Donateo P, Brignole M, Menozzi C, Bottoni N, Alboni P, Dinelli M, Del Rosso A, Croci F, Oddone D, Solano A, Puggioni E. Mechanism of syncope in patients with positive adenosine triphosphate tests. J Am Coll Cardiol. 2003 Jan 1;41(1):93-8. — View Citation

Ermis C, Zhu AX, Pham S, Li JM, Guerrero M, Vrudney A, Hiltner L, Lu F, Sakaguchi S, Lurie KG, Benditt DG. Comparison of automatic and patient-activated arrhythmia recordings by implantable loop recorders in the evaluation of syncope. Am J Cardiol. 2003 Oct 1;92(7):815-9. — View Citation

Hancox JG, Venkat AP, Coldiron B, Feldman SR, Williford PM. The safety of office-based surgery: review of recent literature from several disciplines. Arch Dermatol. 2004 Nov;140(11):1379-82. Review. — View Citation

Inamdar V, Mehta S, Juang G, Cohen T. The utility of implantable loop recorders for diagnosing unexplained syncope in 100 consecutive patients: five-year, single-center experience. J Invasive Cardiol. 2006 Jul;18(7):313-5. — View Citation

Krahn AD, Klein GJ, Fitzpatrick A, Seidl K, Zaidi A, Skanes A, Yee R. Predicting the outcome of patients with unexplained syncope undergoing prolonged monitoring. Pacing Clin Electrophysiol. 2002 Jan;25(1):37-41. — View Citation

Krahn AD, Klein GJ, Norris C, Yee R. The etiology of syncope in patients with negative tilt table and electrophysiological testing. Circulation. 1995 Oct 1;92(7):1819-24. — View Citation

Krahn AD, Klein GJ, Yee R, Norris C. Final results from a pilot study with an implantable loop recorder to determine the etiology of syncope in patients with negative noninvasive and invasive testing. Am J Cardiol. 1998 Jul 1;82(1):117-9. — View Citation

Krahn AD, Klein GJ, Yee R, Skanes AC. Detection of asymptomatic arrhythmias in unexplained syncope. Am Heart J. 2004 Aug;148(2):326-32. — View Citation

Krahn AD, Klein GJ, Yee R, Takle-Newhouse T, Norris C. Use of an extended monitoring strategy in patients with problematic syncope. Reveal Investigators. Circulation. 1999 Jan 26;99(3):406-10. — View Citation

Lombardi F, Calosso E, Mascioli G, Marangoni E, Donato A, Rossi S, Pala M, Foti F, Lunati M. Utility of implantable loop recorder (Reveal Plus) in the diagnosis of unexplained syncope. Europace. 2005 Jan;7(1):19-24. — View Citation

Maggi R, Menozzi C, Brignole M, Podoleanu C, Iori M, Sutton R, Moya A, Giada F, Orazi S, Grovale N. Cardioinhibitory carotid sinus hypersensitivity predicts an asystolic mechanism of spontaneous neurally mediated syncope. Europace. 2007 Aug;9(8):563-7. Epub 2007 May 16. — View Citation

Mason PK, Wood MA, Reese DB, Lobban JH, Mitchell MA, DiMarco JP. Usefulness of implantable loop recorders in office-based practice for evaluation of syncope in patients with and without structural heart disease. Am J Cardiol. 2003 Nov 1;92(9):1127-9. — View Citation

Menozzi C, Brignole M, Garcia-Civera R, Moya A, Botto G, Tercedor L, Migliorini R, Navarro X; International Study on Syncope of Uncertain Etiology (ISSUE) Investigators. Mechanism of syncope in patients with heart disease and negative electrophysiologic test. Circulation. 2002 Jun 11;105(23):2741-5. — View Citation

Mieszczanska H, Ibrahim B, Cohen TJ. Initial clinical experience with implantable loop recorders. J Invasive Cardiol. 2001 Dec;13(12):802-4. — View Citation

Moya A, Brignole M, Menozzi C, Garcia-Civera R, Tognarini S, Mont L, Botto G, Giada F, Cornacchia D; International Study on Syncope of Uncertain Etiology (ISSUE) Investigators. Mechanism of syncope in patients with isolated syncope and in patients with tilt-positive syncope. Circulation. 2001 Sep 11;104(11):1261-7. — View Citation

Paisey JR, Yue AM, Treacher K, Roberts PR, Morgan JM. Implantable loop recorders detect tachyarrhythmias in symptomatic patients with negative electrophysiological studies. Int J Cardiol. 2005 Jan;98(1):35-8. — View Citation

Pakarinen S, Oikarinen L, Toivonen L. Short-term implantation-related complications of cardiac rhythm management device therapy: a retrospective single-centre 1-year survey. Europace. 2010 Jan;12(1):103-8. doi: 10.1093/europace/eup361. — View Citation

Sanfins V, Chaves JC, Alves A, Silva F, Machado I, Quelhas I, Medeiros R, Pires R, Reis D, Pereira A, de Almeida J. Use of an implantable loop recorder: initial experience. Rev Port Cardiol. 2003 Dec;22(12):1479-83. English, Portuguese. — View Citation

Seidl K, Breunung S, Rameken M, Siemon G, Schwacke H, Drögemüller A, Zahn R, Senges J. [Initial experience with an implantable loop recorder in patients with unexplained syncope]. Z Kardiol. 2000 Jan;89(1):43-50. German. — View Citation

Solano A, Menozzi C, Maggi R, Donateo P, Bottoni N, Lolli G, Tomasi C, Croci F, Oddone D, Puggioni E, Brignole M. Incidence, diagnostic yield and safety of the implantable loop-recorder to detect the mechanism of syncope in patients with and without structural heart disease. Eur Heart J. 2004 Jul;25(13):1116-9. — View Citation

Vater M., Rameken M., Pitschner H.F., et al. The endless-loop-recorder in clinical practice - Results of the multicentre German Reveal® registry. Herzschrittmachertherapie und Elektrophysiologie (2002) 13:2 (101-109).

Wiegand UK, LeJeune D, Boguschewski F, Bonnemeier H, Eberhardt F, Schunkert H, Bode F. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest. 2004 Oct;126(4):1177-86. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure-related Complications Rate Requiring Resolution by Surgical Intervention	This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.	From Implant to 90 days post-implant procedure
Secondary	Number of Participants Having Procedure-related Adverse Events	Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).	From Implant to 90 days post-implant procedure
Secondary	Surgical Staff Utilized for Reveal In-office Implants	Observational analysis of surgical staff present at the Reveal Implants	At implant
Secondary	Techniques and Procedures Utilized During Reveal In-office Implants	Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.	At implant
Secondary	Physician Satisfaction With Reveal In-office Implants	Observational survey of physicians satisfaction post implant At implant	At implant
Secondary	R-wave Amplitude Measurement	Average R-wave amplitude at implant and 30-days post procedure	Implant procedure and 30 days post-implant procedure