Atrial FibrillationPhase 4NCT00466973
Atrial Fibrillation Ablation Device Comparison Study
A Phase 4 study testing Dry bipolar radiofrequency (RF) clamp, Unipolar microwave antenna and Unipolar cryothermic probe in people with Atrial Fibrillation, run by Maimonides Medical Center at 1 site in United States.
Trial summary
Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery, a small additional procedure can be done to treat atrial fibrillation. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Dry bipolar radiofrequency (RF) clamp, Unipolar microwave antenna and Unipolar cryothermic probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to May 2009
- Phase
- Phase 4
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing concomitant cardiac surgery who also have AF.
Who cannot join
- Patients undergoing re-do or emergency procedures
- Females of child-bearing age who are pregnant
- Age less than 19 and more than 75 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Ablation Devices Used During Surgery for the Treatment of Atrial Fibrillation
Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery, a small additional procedure can be done to treat atrial fibrillation. Surgeons have a choice of six different devices that he or she can use to treat your atrial fibrillation. It is not known at this point which device is best at treating you, as each device seems to have the same success rate at curing atrial fibrillation. One of the six devices will be selected randomly by card pulled out at the time of enrollment. It is therefore the purpose of this study to compare the devices to each other and to follow up after surgery to determine if any one device is best. This information will be valuable to surgeons and to patients as the treatment for atrial fibrillation develops in the future.
Read the detailed description
Surgery has been used as a treatment for atrial fibrillation (AF) for more than 20 years. Although highly successful, it has not been widely adopted because operations designed to cure AF require extensive cutting and suturing of the heart, inflicting a significant risk on the patient. Newer technologies now permit the surgeon to create similar scars on the heart as cutting, but much more quickly and safely than before.
Over the last ten years at least six different devices have been developed, each of which can scar the heart: Microwave, radiofrequency, ultrasound, laser and cold are some of them. Although there are many papers in the literature studying these devices, each seems to cure about 80% of patients with very low risk of morbidity and/or mortality. This leaves the surgeon with almost no basis upon which to base his or her selection of a device: Which is the best? Which should be used? Therefore, a comparison study is like this is desperately needed.
At the time of the surgery, surgeon who perform the AF treatment, he or she will select one of the six devices mentioned above at randomly assigned earlier, at the time of the enrollment. The device will be used to make scars on your heart exactly as described in the manufacturer's instructions and according to the surgeon's experience. The operation will then be completed per routine. In other words, the only part of the procedure that will be done differently from any other is that the actual device chosen to perform the ablation will vary from one study subject to another.
Patients will be followed up upto one year with EKGs, Holter monitors, MRI's, 6 minute walk tests, echocardiograms, blood tests like bNP and quality of life questionnaires.
- Conditions
- Atrial Fibrillation
- Being tested
- Dry bipolar radiofrequency (RF) clamp, Unipolar microwave antenna, Unipolar cryothermic probe, Irrigated unipolar RF antenna, Irrigated bipolar RF clamp
- Keywords
- Atrial fibrillation, ablation device comparison, ablation in right atria
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry bipolar radiofrequency (RF) clampDevice
Also called AtriCure
Specified device used for ablation during standard surgical procedure
Unipolar microwave antennaDevice
Also called Boston Scientific FLEX 10
Specified device used for ablation during standard surgical procedure
Unipolar cryothermic probeDevice
Also called Cryocath SurgiFrost
Specified device used for ablation during standard surgical procedure
Irrigated unipolar RF antennaDevice
Also called ESTECH Cobra Adhere
Specified device used for ablation during standard surgical procedure
Irrigated bipolar RF clampDevice
Also called Meditronic Cardioblate BP
Specified device used for ablation during standard surgical procedure
Hi-intensity focused ultrasound wandDevice
Also called St. Jude Epicor
Specified device used for ablation during standard surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Dry bipolar radiofrequency (RF) clamp | Active comparator | used for ablation during surgical procedure Receives: Device: Dry bipolar radiofrequency (RF) clamp |
| Unipolar microwave antenna | Active comparator | used for ablation during surgical procedure Receives: Device: Unipolar microwave antenna |
| Unipolar cryothermic probe | Active comparator | used for ablation during surgical procedure Receives: Device: Unipolar cryothermic probe |
| Irrigated unipolar RF antenna | Active comparator | used for ablation during surgical procedure Receives: Device: Irrigated unipolar RF antenna |
| Irrigated bipolar RF clamp | Active comparator | used for ablation during surgical procedure Receives: Device: Irrigated bipolar RF clamp |
| Hi-intensity focused ultrasound wand | Active comparator | used for ablation during surgical procedure Receives: Device: Hi-intensity focused ultrasound wand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial fibrillation
No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, Brain Natriuretic Peptide (BNP) levels
Measured: 3 months after surgery
Rhythm at 12 months
No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, BNP levels
Measured: 12 months after surgery
Major Adverse Cardiovascular Events (MACEs) at 1 and 3 months
Recording any major adverse cardiovascular events reported
Measured: 1 and 3 months post-surgical procedure
Secondary outcomes (3)
Functional and qualitative improvement in heart failure, ejection fraction, left atrial size, exercise tolerance
Quality of life questionnaire
Measured: 6 and 12 months post-surgical procedure
Rhythm at 3, 6 and 9 months
No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, BNP levels
Measured: 3, 6 and 9 months post-surgical procedure
All other adverse events
Any adverse events noted throughout period
Measured: From surgical procedure through 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completion20 Nov 2008
- Study completionMay 2009 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam E Saltman, MD, Principal investigator, Director Atrial fibrillation Program, Cardiothoracic SurgeonKamran B Ali, MD, Principal investigator, Cardiology Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466973
- Sponsor's protocol ID
- 06/11/VA07
- Status last verified
- Aug 2018
- First submitted
- 25 Apr 2007
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Ablation Devices Used During Surgery for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00466973
- Acronym / sponsor ID
- 06/11/VA07
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, ablation device comparison, ablation in right atria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- 20 Nov 2008 (actual)
- Study completion
- May 2009 (estimated)
- First posted
- 27 Apr 2007 (estimated)
- 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.
Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery, a small additional procedure can be done to treat atrial fibrillation. Surgeons have a choice of six different devices that he or she can use to treat your atrial fibrillation. It is not known at this point which device is best at treating you, as each device seems to have the same success rate at curing atrial fibrillation. One of the six devices will be selected randomly by card pulled out at the time of enrollment. It is therefore the purpose of this study to compare the devices to each other and to follow up after surgery to determine if any one device is best. This information will be valuable to surgeons and to patients as the treatment for atrial fibrillation develops in the future.
Detailed description
Surgery has been used as a treatment for atrial fibrillation (AF) for more than 20 years. Although highly successful, it has not been widely adopted because operations designed to cure AF require extensive cutting and suturing of the heart, inflicting a significant risk on the patient. Newer technologies now permit the surgeon to create similar scars on the heart as cutting, but much more quickly and safely than before.
Over the last ten years at least six different devices have been developed, each of which can scar the heart: Microwave, radiofrequency, ultrasound, laser and cold are some of them. Although there are many papers in the literature studying these devices, each seems to cure about 80% of patients with very low risk of morbidity and/or mortality. This leaves the surgeon with almost no basis upon which to base his or her selection of a device: Which is the best? Which should be used? Therefore, a comparison study is like this is desperately needed.
At the time of the surgery, surgeon who perform the AF treatment, he or she will select one of the six devices mentioned above at randomly assigned earlier, at the time of the enrollment. The device will be used to make scars on your heart exactly as described in the manufacturer's instructions and according to the surgeon's experience. The operation will then be completed per routine. In other words, the only part of the procedure that will be done differently from any other is that the actual device chosen to perform the ablation will vary from one study subject to another.
Patients will be followed up upto one year with EKGs, Holter monitors, MRI's, 6 minute walk tests, echocardiograms, blood tests like bNP and quality of life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dry bipolar radiofrequency (RF) clamp | Active comparator | Device: Dry bipolar radiofrequency (RF) clampused for ablation during surgical procedure |
| Unipolar microwave antenna | Active comparator | Device: Unipolar microwave antennaused for ablation during surgical procedure |
| Unipolar cryothermic probe | Active comparator | Device: Unipolar cryothermic probeused for ablation during surgical procedure |
| Irrigated unipolar RF antenna | Active comparator | Device: Irrigated unipolar RF antennaused for ablation during surgical procedure |
| Irrigated bipolar RF clamp | Active comparator | Device: Irrigated bipolar RF clampused for ablation during surgical procedure |
| Hi-intensity focused ultrasound wand | Active comparator | Device: Hi-intensity focused ultrasound wandused for ablation during surgical procedure |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing concomitant cardiac surgery who also have AF.
Key exclusion criteria (3 listed)
- Patients undergoing re-do or emergency procedures
- Females of child-bearing age who are pregnant
- Age less than 19 and more than 75 years old
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 |
|---|---|---|
| Dry bipolar radiofrequency (RF) clampAlso: AtriCureSpecified device used for ablation during standard surgical procedure | Device | Dry bipolar radiofrequency (RF) clamp |
| Unipolar microwave antennaAlso: Boston Scientific FLEX 10Specified device used for ablation during standard surgical procedure | Device | Unipolar microwave antenna |
| Unipolar cryothermic probeAlso: Cryocath SurgiFrostSpecified device used for ablation during standard surgical procedure | Device | Unipolar cryothermic probe |
| Irrigated unipolar RF antennaAlso: ESTECH Cobra AdhereSpecified device used for ablation during standard surgical procedure | Device | Irrigated unipolar RF antenna |
| Irrigated bipolar RF clampAlso: Meditronic Cardioblate BPSpecified device used for ablation during standard surgical procedure | Device | Irrigated bipolar RF clamp |
| Hi-intensity focused ultrasound wandAlso: St. Jude EpicorSpecified device used for ablation during standard surgical procedure | Device | Hi-intensity focused ultrasound wand |
Primary outcome
Freedom from Atrial fibrillation
Time frame: 3 months after surgery
No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, Brain Natriuretic Peptide (BNP) levels
Rhythm at 12 months
Time frame: 12 months after surgery
No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, BNP levels
Major Adverse Cardiovascular Events (MACEs) at 1 and 3 months
Time frame: 1 and 3 months post-surgical procedure
Recording any major adverse cardiovascular events reported
3 secondary outcomes
Functional and qualitative improvement in heart failure, ejection fraction, left atrial size, exercise tolerance
Time frame: 6 and 12 months post-surgical procedure
Rhythm at 3, 6 and 9 months
Time frame: 3, 6 and 9 months post-surgical procedure
All other adverse events
Time frame: From surgical procedure through 12 months follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
Adam E Saltman, MD principal investigator
Director Atrial fibrillation Program, Cardiothoracic Surgeon
Kamran B Ali, MD principal investigator
Cardiology Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dry bipolar radiofrequency (RF) clamp, Unipolar microwave antenna and Unipolar cryothermic probe in people with Atrial Fibrillation, run by Maimonides 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 17 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Freedom from Atrial fibrillation (time frame: 3 months after surgery). The study lists 3 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 17 Aug 2018.