Atrial FibrillationNCT03786822
Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
A study testing Cryoballoon Pulmonary Vein Isolation - PVI in people with Atrial Fibrillation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cryoballoon Pulmonary Vein Isolation - PVI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 20 Dec 2016
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs
- Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy.
Who cannot join
- Planned use of radiofrequency cardiac ablation
- Presence of a cardiac implantable electronic device
- Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus
- Patients with active systemic infections
- Patients with cryoglobulinemia
- Pregnant and/or breast-feeding females are excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern
Dallas, Texas, 75390
About this study
This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation.
One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.
Read the detailed description
Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is used to destroy the atrial tissue which propagate electrical impulses into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and efficacious under fluoroscopic guidance with contrast angiography. The objective of this study is to identify methods to reduce radiation dose and radio opaque contrast use while maintaining PVI efficacy and safety.
- Conditions
- Atrial Fibrillation
- Being tested
- Cryoballoon Pulmonary Vein Isolation - PVI
- Keywords
- cryoballoon, Atrial fibrillation, pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon Pulmonary Vein Isolation - PVIProcedure or surgery
Also called Atrial Fibrillation Ablation
A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.
| Study group | Role | What they receive |
|---|---|---|
| Non-fluoroscopic Cryoballoon PVI | Experimental | 1. Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform.
2. Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks.
3. Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium. Receives: Procedure: Cryoballoon Pulmonary Vein Isolation - PVI |
| Fluoroscopic Cryoballoon PVI | Active comparator | Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography Receives: Procedure: Cryoballoon Pulmonary Vein Isolation - PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.
change in the composite endpoint of total fluoroscopy time (min)
Measured: one year
Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.
change in the composite endpoint of contrast (cc)
Measured: one year
Secondary outcomes (2)
Recurrence of atrial fibrillation
•recurrence of atrial fibrillation after 1 month blanking period measured by ECG event monitoring at 6 and 12 month follow up (time to first recurrence in months, total number of episodes, and total duration in hours)
Measured: one year
Time to Cryoballoon Pulmonary Vein Isolation
•cryoballoon procedure time (min)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Jun 2015
- Primary completion20 Dec 2016
- Study completion20 Dec 2016
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.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Condition or Disease: Paroxysmal atrial fibrillation Procedure: Cryoballoon Pulmonary Vein Isolation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Richard Wu, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786822
- Sponsor's protocol ID
- STU 042013-074
- Status last verified
- Dec 2018
- First submitted
- 29 Nov 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT03786822
- Acronym / sponsor ID
- STU 042013-074
- Conditions
- Atrial Fibrillation
- Keywords
- cryoballoon, Atrial fibrillation, pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 26 Dec 2018 (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.
This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation.
One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.
Detailed description
Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is used to destroy the atrial tissue which propagate electrical impulses into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and efficacious under fluoroscopic guidance with contrast angiography. The objective of this study is to identify methods to reduce radiation dose and radio opaque contrast use while maintaining PVI efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Condition or Disease: Paroxysmal atrial fibrillation Procedure: Cryoballoon Pulmonary Vein Isolation
| Arm | Type | Receives |
|---|---|---|
| Non-fluoroscopic Cryoballoon PVI | Experimental | Procedure: Cryoballoon Pulmonary Vein Isolation - PVI1. Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform. 2. Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks. 3. Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium. |
| Fluoroscopic Cryoballoon PVI | Active comparator | Procedure: Cryoballoon Pulmonary Vein Isolation - PVIStandard cryoballoon PVI using radio opaque contrast pulmonary vein angiography |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs
- Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy.
Key exclusion criteria (6 listed)
- Planned use of radiofrequency cardiac ablation
- Presence of a cardiac implantable electronic device
- Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus
- Patients with active systemic infections
- Patients with cryoglobulinemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoballoon Pulmonary Vein Isolation - PVIAlso: Atrial Fibrillation AblationA 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time. | Procedure or surgery | Fluoroscopic Cryoballoon PVI, Non-fluoroscopic Cryoballoon PVI |
Primary outcome
Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.
Time frame: one year
change in the composite endpoint of total fluoroscopy time (min)
Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.
Time frame: one year
change in the composite endpoint of contrast (cc)
2 secondary outcomes
Recurrence of atrial fibrillation
Time frame: one year
Time to Cryoballoon Pulmonary Vein Isolation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon Pulmonary Vein Isolation - PVI in people with Atrial Fibrillation, run by University of Texas Southwestern Medical Center 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 2 inclusion and 6 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 26 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation. (time frame: one year). The study lists 2 primary outcomes in all. 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 26 Dec 2018.