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Arrhythmias, CardiacNCT01168427

Reveal In-Office Implants

An observational study of Arrhythmias, Cardiac, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arrhythmias, Cardiac
What is being tested?
Reveal® DX or Reveal® XT Insertable Cardiac Monitor
How many people
66 participants
Where
9 sitesUnited States
Study dates
Aug 2010to May 2011
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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: All patients recruited for participation in study were indicated for continuous arrhythmia monitoring.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Study site

    Amarillo, Texas

  • Study site

    Greensboro, North Carolina

  • Study site

    Kettering, Ohio

  • Study site

    La Jolla, California

  • Study site

    Macon, Georgia

  • Study site

    Miramar, Florida

  • Study site

    Munster, Indiana

  • Study site

    San Antonio, Texas

  • Study site

    Takoma Park, Maryland

Other trials in United States

About this study

Official title: Reveal® In-Office Implants Study

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.

Being tested
Reveal® DX or Reveal® XT Insertable Cardiac Monitor
Medical subject headings
Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reveal® DX or Reveal® XT Insertable Cardiac MonitorDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Implant to 90 days post-implant procedure

Secondary outcomes (5)

  1. 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).

    Measured: From Implant to 90 days post-implant procedure

  2. Surgical Staff Utilized for Reveal In-office Implants

    Observational analysis of surgical staff present at the Reveal Implants

    Measured: At implant

  3. 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.

    Measured: At implant

  4. Physician Satisfaction With Reveal In-office Implants

    Observational survey of physicians satisfaction post implant At implant

    Measured: At implant

  5. R-wave Amplitude Measurement

    Average R-wave amplitude at implant and 30-days post procedure

    Measured: Implant procedure and 30 days post-implant procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

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
Case only
Time perspective
Prospective
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01168427
Sponsor's protocol ID
Reveal In-Office Implants
Status last verified
Jan 2018
First submitted
21 Jul 2010
Last updated
28 Feb 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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. doi: 10.1161/01.cir.99.3.406.

    PubMed 9918528

  • 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. doi: 10.1016/j.ehj.2004.05.013.

    PubMed 15231369

  • Krahn AD, Klein GJ, Yee R, Skanes AC. Detection of asymptomatic arrhythmias in unexplained syncope. Am Heart J. 2004 Aug;148(2):326-32. doi: 10.1016/j.ahj.2004.01.024.

    PubMed 15309004

  • 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. doi: 10.1161/hc3601.095708.

    PubMed 11551877

  • 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. doi: 10.1001/archderm.140.11.1379.

    PubMed 15545548

  • 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. doi: 10.1161/01.cir.92.7.1819.

    PubMed 7671366

  • 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. doi: 10.1016/s0002-9149(98)00237-9.

    PubMed 9671019

  • Seidl K, Breunung S, Rameken M, Siemon G, Schwacke H, Drogemuller 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. doi: 10.1007/s003920050007. German.

    PubMed 10663916

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

    PubMed 11731693

  • 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. doi: 10.1046/j.1460-9592.2002.00037.x.

    PubMed 11877934

  • 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. doi: 10.1093/ageing/32.2.185.

    PubMed 12615562

  • 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.

    PubMed 15008063

  • 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. doi: 10.1016/j.amjcard.2003.07.011.

    PubMed 14583373

  • 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. doi: 10.1016/s0735-1097(02)02621-9.

    PubMed 12570950

  • 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. doi: 10.1016/s0002-9149(03)00889-0.

    PubMed 14516882

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmias, Cardiac, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in United States.

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 5 inclusion and 7 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: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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?

Yes. Results are posted in the registry (first posted 26 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Procedure-related Complications Rate Requiring Resolution by Surgical Intervention (time frame: From Implant to 90 days post-implant procedure). 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 NCT01168427, which also lists 28 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 28 Feb 2018.

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