Implanted Loop Recorder Post Atrial Fibrillation Ablation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Thoracic & Cardiovascular Healthcare Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Medtronic
AtriCure, Inc.
Information provided by:
Thoracic & Cardiovascular Healthcare Foundation
ClinicalTrials.gov Identifier:
NCT00915720
First received: June 4, 2009
Last updated: July 19, 2011
Last verified: July 2010
  Purpose

This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Implanted Loop Recorder Surveillance of Recurrent Atrial Fibrillation After Atrial Fibrillation Ablation

Resource links provided by NLM:


Further study details as provided by Thoracic & Cardiovascular Healthcare Foundation:

Primary Outcome Measures:
  • Incidence/Duration of atrial and tachyarrhythmias post AF ablation [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Atrial Fibrillation (AF)is the most common arrhythmia and causes significant morbidity and mortality. Treatment for AF consists of medical therapy and ablation therapy. Medical therapies can help approximately 50% of patients, the rest must resort to ablation procedures.

Ablation procedures aim to isolate the pulmonary vein from the atrial tissue electrically and can be performed either endocardially through catheters inserted through the femoral veins or epicardially through a minimal lateral thoracotomy. Both procedures are accepted as standard of care.

Recurrent AF after ablation therapy can be common and occurs in 50% of patients and could be in a form of short periods of AF or persistent AF with less or minimal symptoms. This is of significant clinical relevance as most of these AF episodes are not recognized and can lead to thromboembolic events such as stroke. However, techniques of surveillance of AF post ablation have been suboptimal. Physicians could use holter monitoring but this is limited to a short period of 24 - 48 hours. Event recorders which are external can be used but patients need to experience symptoms associated with the AF episodes in order to record the episodes.

Better AF monitoring techniques especially after AF ablation are necessary so that recognition of AF recurrence in these patient could be possible and timely anticoagulation therapy initiated may prevent strokes.

This pilot study involves implanting a loop recorder just under the skin to record cardiac rhythms 24 hours per day without any interaction by the patient. These devices are currently approved by the FDA for monitoring of syncope and will be implanted during the patients AF ablation surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing surgical atrial fibrillation

Criteria

Inclusion Criteria:

  • Patients undergoing surgical atrial fibrillation ablation
  • Patients must be 18 years or older

Exclusion Criteria:

  • Patients unwilling to comply with the follow up schedule
  • Pregnant or breastfeeding patients
  • Patients currently participating in another study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915720

Locations
United States, Michigan
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48910
Sponsors and Collaborators
Thoracic & Cardiovascular Healthcare Foundation
Medtronic
AtriCure, Inc.
Investigators
Principal Investigator: John H Ip, MD Thoracic & Cardiovascular Healthcare Foundation
  More Information

No publications provided

Responsible Party: John H. Ip, MD FACC, Thoracic & Cardiovascular Healthcare Foundation
ClinicalTrials.gov Identifier: NCT00915720     History of Changes
Other Study ID Numbers: ILR 1208
Study First Received: June 4, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Thoracic & Cardiovascular Healthcare Foundation:
Atrial Fibrillation
Surgical Ablation
Implanted loop recorder
Atrial Fibrillation Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014