- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04859933
AV Node Isolation in Atrial Fibrillation vs. Modulation by "Pace and Ablate" Strategy
August 8, 2022 updated by: Heart and Diabetes Center North-Rhine Westfalia
AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation with numerous side effects.
The investigators hypothesised that an isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks, more frequent preservation and higher rate of escape rhythm compared to AVNA.
This retrospective study includes 20 patients being treated with AV-node isolation (AVNI) and 40 historical AVNA-controls.
Among others these two methods were compared regarding escape rhythm, delta QRS, procedure time, ablation points, fluoroscopy time and total dose area product (DAP).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bad Oeynhausen, Germany, 32545
- Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to Heart- and Diabetes Centre NRW for AV-node ablation/isolation.
Description
Inclusion Criteria:
- paroxysmal, persistend or permanent atrial fibrillation; indication for AVNA
Exclusion Criteria:
- other indications for AVNA than atrial fibrillation as AVNRT, atrial flutter, atrial tachycardia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AVNA group
Group of historical controls beeing treated with AV-node ablation
|
Right sided ablation of the AV-node
Other Names:
|
AVNI group
Inculudes all patients beeing treated with AV-node isolation
|
Abaltion performed in the right atrium isolating the AV-node from the atrium
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AV-node escape rhythm
Time Frame: intraoperative, follow-up after 1 to 3 month
|
intraoperative, follow-up after 1 to 3 month
|
bundle branch blocks
Time Frame: intraoperative, follow-up after 1 to 3 month
|
intraoperative, follow-up after 1 to 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
April 22, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (Actual)
April 26, 2021
Study Record Updates
Last Update Posted (Actual)
August 9, 2022
Last Update Submitted That Met QC Criteria
August 8, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HDZ_ER_003_GI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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