Persistent Atrial FibrillationDEEPNCT01246466

Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study

A study testing Hybrid: AtriCure Bipolar System & EP ablation procedure in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by AtriCure, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
What is being tested?: Hybrid: AtriCure Bipolar System & EP ablation procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 5 sitesUnited States
Study dates: Dec 2010to Nov 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age > 18 years
Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
Patient is willing and able to provide written informed consent.
Patient has a life expectancy of at least 2 years.
Patient is willing and able to attend the scheduled follow-up visits.

Who cannot join

Prior Cardiothoracic Surgery.
Patient has NYHA Class IV heart failure.
Evidence of underlying structural heart disease requiring surgical treatment.
Ejection fraction < 30%
Measured left atrial diameter > 6.0 cm
Renal Failure

Show all 15Show fewer

Stroke within previous 6 months.
Known carotid artery stenosis greater than 80%.
Evidence of significant active infection or endocarditis.
Pregnant woman or women desiring to become pregnant in the next 24 months.
Presence of thrombus in the left atrium determined by echocardiography.
History of blood dyscrasia.
Contraindication to anticoagulation, based on Investigator's opinion.
Mural thrombus or tumor.
Moderate to Severe COPD

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

UVA
Charlottesville, Virginia, 22908
Vanderbilt Heart Institute
Nashville, Tennessee, 37232
Sentara Norfolk
Norfolk, Virginia, 23507
Baylor Health
Plano, Texas, 75093
Stanford University Medical Center
Stanford, California, 94305

Other trials in United States

About this study

Official title: Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Conditions: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Being tested: Hybrid: AtriCure Bipolar System & EP ablation procedure
Keywords: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Ablation, Catheter ablation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hybrid: AtriCure Bipolar System & EP ablation procedureDevice
AtriCure Bipolar System plus a catheter ablation

Study groups in NCT01246466
Study group	Role	What they receive
AtriCure Bipolar System combined with a catheter ablation	Experimental	procedure using the AtriCure Bipolar System plus a catheter ablation Receives: Device: Hybrid: AtriCure Bipolar System & EP ablation procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Safety Endpoint
Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
Measured: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
Absence of Atrial Fibrillation
Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.
Measured: 12 month follow-up

Secondary outcomes (7)

Overall Serious Device or Procedure Related Adverse Event Rate
Measured: 12 month follow-up
Acute Procedure Success
Measured: Upon completion of the index procedure, up to ten hours
Absence of Atrial Fibrillation
Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.
Measured: After the 3 month blanking period through twelve month follow-up.
Number of Participants With Reintervention to Address Atrial Dysrhythmia
Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months
Measured: 12 months
Number of Participants With DC Cardioversion
Measured: 12 months
Improvement in AF
Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0)
Measured: 12 months
Duration of Procedure
Measured: During index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Nov 2013

First posted23 Nov 2010 (estimated)
Study startDec 2010
Primary completionDec 2012
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Persistent 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01246466
Sponsor's protocol ID: CP2009-1
Acronym: DEEP
Status last verified: Jan 2016
First submitted: 22 Nov 2010
Last updated: 1 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Recruiting
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
Persistent Atrial Fibrillation

All Persistent Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation
ClinicalTrials.gov ID: NCT01246466
Acronym / sponsor ID: DEEP / CP2009-1
Conditions: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Keywords: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Ablation, Catheter ablation
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: AtriCure, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2010 (actual)
Primary completion: Dec 2012 (actual)
Study completion: Nov 2013 (actual)
First posted: 23 Nov 2010 (estimated)
Results: Posted 1 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AtriCure Bipolar System combined with a catheter ablation	Experimental	Device: Hybrid: AtriCure Bipolar System & EP ablation procedureprocedure using the AtriCure Bipolar System plus a catheter ablation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age > 18 years
Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
Patient is willing and able to provide written informed consent.
Patient has a life expectancy of at least 2 years.
Patient is willing and able to attend the scheduled follow-up visits.

Key exclusion criteria (15 listed)

Prior Cardiothoracic Surgery.
Patient has NYHA Class IV heart failure.
Evidence of underlying structural heart disease requiring surgical treatment.
Ejection fraction < 30%
Measured left atrial diameter > 6.0 cm

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
Hybrid: AtriCure Bipolar System & EP ablation procedureAtriCure Bipolar System plus a catheter ablation	Device	AtriCure Bipolar System combined with a catheter ablation

Primary outcome

Primary Safety Endpoint
Time frame: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
Absence of Atrial Fibrillation
Time frame: 12 month follow-up
Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.

7 secondary outcomes

Overall Serious Device or Procedure Related Adverse Event Rate
Time frame: 12 month follow-up
Acute Procedure Success
Time frame: Upon completion of the index procedure, up to ten hours
Absence of Atrial Fibrillation
Time frame: After the 3 month blanking period through twelve month follow-up.
Number of Participants With Reintervention to Address Atrial Dysrhythmia
Time frame: 12 months
Number of Participants With DC Cardioversion
Time frame: 12 months
Improvement in AF
Time frame: 12 months
Duration of Procedure
Time frame: During index procedure

Results and safety

Results posted to the registry on 1 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AtriCure Bipolar System Combined With a Catheter Ablation	24	22

Primary outcome: Primary Safety Endpoint

Time frame: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	AtriCure Bipolar System Combined With a Catheter Ablation n = 24
Death per IPA	0 (0.0 to 14.2)
Excessive bleeding per IPA	0 (0.0 to 14.2)
Stroke per IPA	4.2 (0.1 to 21.1)
TIA per IPA	0 (0.0 to 14.2)
MI per IPA	4.2 (0.1 to 21.1)
Cardiac Tamponade per IPA	0 (0.0 to 14.2)
Pulmonary Embolism per IPA	0 (0.0 to 14.2)
Peripheral Embolism per IPA	0 (0.0 to 14.2)

Primary outcome: Absence of Atrial Fibrillation

Time frame: 12 month follow-up. Number (95% Confidence Interval). Unit: percentage of participants

Measure	AtriCure Bipolar System Combined With a Catheter Ablation n = 19
Success at 12 Months	68.4 (43.4 to 87.4)
Failure by AAD	10.5 (1.3 to 33.1)
Failure by Holter/Pacemaker Interrogation	21.1 (6.1 to 45.6)
Atrial Fibrillation	0.0 (0.0 to 17.6)
Atrial Flutter	0 (0.0 to 17.6)
Atrial Tachycardia	21.1 (6.1 to 45.6)
Failure by both AAD and Holter/Pacemaker Interrog	0.0 (0.0 to 17.6)

Population analysed: Denominators (19) are subjects who are evaluable for primary efficacy endpoint.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment to 24 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AtriCure Bipolar System Combined With a Catheter Ablation	16 of 24 (66.7%)	20 of 24 (83.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Persistent Atrial Fibrillation

Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Recruiting
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
Persistent Atrial Fibrillation

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.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 15 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Safety Endpoint (time frame: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.). 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?

On the ClinicalTrials.gov record for NCT01246466.

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 1 Apr 2021.