Evaluation of the effect of ablation technique with radiofrequency waveforms in the treatment of supraventricular arrhythmia
Design
Phase IV clinical trial with one intervention group without control group, consisted of 80 participants
Settings and conduct
After undergoing primary electrophysiologic examination to determine the type of supraventricular tachyarrhythmia and the target points, patients referring to Ayatollah Rohani Hospital in Babol will be subjected to ablation. The radio frequency energy will be generated by a generator that produced continuous flow with a frequency of 500 Hz. For ablation, the radiofrequency flow will be applied to target points for 10 minutes at 30 watts.
Participants/Inclusion and exclusion criteria
Inclusion criteria: symptomatic and life threatening tachyarrhythmias, resistant to drug therapy or drug-related adverse events. Exclusion criteria: Patients with valvulopathy, tachycardia less than once a week, atrial fibrillation or atrial flutter, and pregnancy
Intervention groups
Application of radiofrequency flow with power of 30 watts at target location for 10 minutes
Main outcome variables
AV block; stroke; pneumothorax; deep vein thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160926029976N5
Registration date:2019-06-09, 1398/03/19
Registration timing:registered_while_recruiting
Last update:2019-06-09, 1398/03/19
Update count:0
Registration date
2019-06-09, 1398/03/19
Registrant information
Name
Reza Mohseni Ahangar
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
r.mohseni@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ablation technique with radiofrequency waveforms in the treatment of supraventricular arrhythmia
Public title
Evaluation of ablation in the treatment of arrhythmia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symptomatic, life-threatening tachyarrhythmia that is resistant to drug therapy
Symptomatic, life-threatening tachyarrhythmia that has adverse effects of drug
Exclusion criteria:
Cardiac valvular disease
Tachycardia period less than once a week
Atrial fibrillation
Pregnancy
Atrial Flutter
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Parastar Square, Keshavarz street, Babol
City
Babol
Province
Mazandaran
Postal code
4717995915
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.260
Health conditions studied
1
Description of health condition studied
Supraventricular tachyarrythmia
ICD-10 code
I47.1
ICD-10 code description
Supraventricular tachycardia
Primary outcomes
1
Description
Atrioventricular block
Timepoint
Evaluation of atrioventricular block 3 months after intervention
Method of measurement
Electrocardiogram
2
Description
Pneumothorax
Timepoint
Evaluation of pneumothorax 3 months after intervention
Method of measurement
Chest X ray
3
Description
Deep vein thrombosis
Timepoint
Evaluation of deep vein thrombosis 3 months after intervention
Method of measurement
Doppler ultrasonography of lower extremities
4
Description
Stroke
Timepoint
Evaluation of stroke 3 months after intervention
Method of measurement
physical examination and brain magnetic resonance imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After undergoing primary electrophysiologic examination to determine the type of supraventricular tachyarrhythmia and determine the target points, patients are subjected to ablation. The radio frequency energy will be generated by a generator that produced continuous flow with a frequency of 500 Hz. For ablation, the radiofrequency flow will be applied to target locations for 10 minutes at 30 watts.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani hospital
Full name of responsible person
Mahsa Akbarian
Street address
Parastar square, Keshavarz boulevard
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
Akbarian_mahsa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Babol University Of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University Of Medical Sciences, Parastar square, Keshavarz blvd
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Babol University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahsa Akbarian
Position
Residency of Cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Rouhani Hospital, Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Fax
Email
Akbarian_mahsa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahsa Akbarian
Position
Residency in cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Fax
Email
Akbarian_mahsa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Reza Mohseni Ahangar
Position
fellowship in pulmonology
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Fax
Email
r.mohseni@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available