Atrial FibrillationNCT03148392
Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation
An observational study of Atrial Fibrillation, run by Sumit Verma, MD at 1 site in United States.
Trial summary
The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiology
Who may be able to join
- Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment.
Who cannot join
- Persistent atrial fibrillation
- Pregnant
- Taking pain medications for acute or chronic conditions at the time of the procedure.
- Undergo a combination of Cryoablation and Radiofrequency ablation
- Radiofrequency group who undergo ablation beyond pulmonary vein isolation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cardiology Consultants
Pensacola, Florida, 32501
Research Manager, 850-484-6690
About this study
Official title: A Prospective Comparison of Quality of Life Following Atrial Fibrillation Ablation Using the Arctic Front Advance Cryo Balloon Compared to Contact Force Sensing Radiofrequency Catheter Ablation
The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.
Read the detailed description
Currently there are several different accepted techniques for performing ablation of atrial fibrillation. The two primary techniques currently in use in our center for atrial fibrillation are Cryo Balloon and Radiofrequency ablation.
Based on personal observation, it is felt that patients undergoing Radiofrequency ablation have a higher incidence of chest discomfort and subsequently a greater requirement for pain medications post procedure as compared to those patients undergoing Cryo ablation.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cryo Balloon Ablation | Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference | |
| Radiofrequency Ablation | Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measurement
Self report pain intensity measured at baseline and then once a day beginning at least four hours after the ablation. Three individual pain scales will be used. Universal Pain Assessment Tool is scored 0 to 10 with 0 = no pain and 10 = severe.
Measured: 7 Days
Secondary outcomes (2)
Health Status and Activity Measurement
Self report health status and activity measured at baseline and then once a day beginning at least four hours after the ablation using SF-36 Health and Well-Being Questionnaire.
Measured: 7 Days
Pain Medication Assessment
Assess amount and duration of pain medication required post ablation
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start16 May 2017
- Primary completion1 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumit Verma, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Sumit Verma, MD, Langhorne Cardiology Consultants, Inc.
- Investigators
- Sumit Verma, MD, Principal investigator, Cardiology Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148392
- Sponsor's protocol ID
- Cryo RF Ablation QOL
- Status last verified
- Aug 2019
- First submitted
- 27 Apr 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Quality of Life Following Atrial Fibrillation Ablation Using the Arctic Front Advance Cryo Balloon Compared to Contact Force Sensing Radiofrequency Catheter Ablation
- ClinicalTrials.gov ID
- NCT03148392
- Acronym / sponsor ID
- Cryo RF Ablation QOL
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sumit Verma, MDUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 16 May 2017 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.
Detailed description
Currently there are several different accepted techniques for performing ablation of atrial fibrillation. The two primary techniques currently in use in our center for atrial fibrillation are Cryo Balloon and Radiofrequency ablation.
Based on personal observation, it is felt that patients undergoing Radiofrequency ablation have a higher incidence of chest discomfort and subsequently a greater requirement for pain medications post procedure as compared to those patients undergoing Cryo ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryo Balloon Ablation | – | –Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference |
| Radiofrequency Ablation | – | –Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology
Key inclusion criteria (1 listed)
- Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment.
Key exclusion criteria (5 listed)
- Persistent atrial fibrillation
- Pregnant
- Taking pain medications for acute or chronic conditions at the time of the procedure.
- Undergo a combination of Cryoablation and Radiofrequency ablation
- Radiofrequency group who undergo ablation beyond pulmonary vein isolation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Intensity Measurement
Time frame: 7 Days
Self report pain intensity measured at baseline and then once a day beginning at least four hours after the ablation. Three individual pain scales will be used. Universal Pain Assessment Tool is scored 0 to 10 with 0 = no pain and 10 = severe.
2 secondary outcomes
Health Status and Activity Measurement
Time frame: 7 Days
Pain Medication Assessment
Time frame: 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumit Verma, MD principal investigator
Cardiology Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Sumit Verma, MD at 1 site 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Manager (850-484-6690, Jennifer.Lehmann@bhcpns.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measurement (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2019.