Atrial FibrillationCRYO-LANCT00821015

Effect of Balloon Cryoablation on Left Atrial Function

A study testing Pulmonary vein isolation with cryoballoon catheter in people with Atrial Fibrillation, run by Vivek Reddy.

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 to 85 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: Pulmonary vein isolation with cryoballoon catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: No sites listed yet
Study dates: Jun 2010to Jun 2012
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented paroxysmal atrial fibrillation
≥ 18 and ≤ 85 years of age
Failure of one or more AF Drugs (AFDs).
Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
Ability to understand the requirements of the study
Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Who cannot join

Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
More than 4 cardioversions in the prior year.
Patients with recent myocardial infarction (less than 2 months) or unstable angina.
Patients with congestive heart failure (NYHA class III or IV).
Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.
Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure.
Patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
Patients whose life expectancy is less than one year.

About this study

Official title: Effect of Balloon Cryoablation on Left Atrial Function (CRYO-LA)

Atrial fibrillation is a common and disabling irregular heart rhythm, that affects 1 to 1.5 million Americans. Recent clinical experience with the Medtronic Arctic Front™ Cardiac CryoAblation Catheter System suggests that it can be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF, thereby reducing or eliminating the recurrence of AF.3-4 However, the very large ablative surface of this balloon ablation catheter raises the possibility that this technique may damage extensive areas of the atrial myocardium.

The LA is an elastic chamber, designed to expand and contract with ease to accommodate the influx and outflow of blood, while maintaining relatively low pressure. When exposed to stress or injury, whether acute or chronic, the LA may lose much of its elasticity, resulting in overall dilation accompanied by fibrosis in some cases. Overall, this may potentially result in diminution of LA mechanical function (both systolic contractile function, and diastolic relaxation function). In addition, LA function is linked to both Left Ventricular (LV) systolic and diastolic function, manifesting in an overall impact on cardiac remodeling, including the area of the pulmonary vein ostia, and a significant decrease in LV ejection fraction (LVEF). On the other hand, the positive effects of maintaining sinus rhythm with successful catheter ablation of AF may result in improvement of LA mechanical function.5-9

Based on the potentially deleterious effects of damage caused by cryoablation, to the atrial myocardium during balloon ablation, this prospective, non-randomized, single-center study has been designed to assess the atrial effects of balloon cryo-ablation.

Read the detailed description

This study is a prospective, non-randomized, single-center, controlled study of patients with AF referred for ablation after failing one or more Class I-IV antiarrhythmic drugs used in the treatment of AF.

All study subjects will undergo cryoablation.

Subjects will be followed for 12 months to assess the chronic impact of ablation with the Medtronic CryoCath Arctic Front™ Cardiac CryoAblation Catheter System on LA and LV mechanical function. In addition, patients will undergo scheduled and symptom-driven assessments to detect recurrent AF and adverse events (AEs).

We will evaluate the effect of ablation with the Medtronic Arctic Front™ Cardiac CryoAblation Catheter System on the atrial myocardium, with respect to LA (and LV) mechanical function, by assessing images acquired using TTE and CT in adult patients with atrial fibrillation who have failed at least one anti-arrhythmic drug. The efficacy of the Arctic Front™ Cardiac CryoAblation Catheter System will be assessed by ambulatory continuous ECG monitoring

Conditions: Atrial Fibrillation
Being tested: Pulmonary vein isolation with cryoballoon catheter
Keywords: cryoablation, recurring arrhythmia, stroke, RF ablation, LA ablation, nodal ablation, catheter ablation
Medical subject headings: Atrial Fibrillation, Stroke

What participants receive

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

Pulmonary vein isolation with cryoballoon catheterDevice
For each patient, the balloon catheter will be advanced to the ostium of each pulmonary vein. Once location has been optimized, the balloon will be inflated, and cryoenergy delivery will be initiated. Because the entire surface of the balloon acts as an ablative surface, circumferential ablation of each pulmonary vein will be achieved concurrently. This will be completed for each pulmonary vein for each patient.

Study groups in NCT00821015
Study group	Role	What they receive
Experimental	Experimental	All study subjects will undergo cryoablation. This is a non-randomized trial. Receives: Device: Pulmonary vein isolation with cryoballoon catheter

What is being measured

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

Number of Participants With Acute Procedural Success (APS)
Acute Procedural Success (APS) is the demonstration of electrical isolation of all 4 PVs or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
Measured: Immediately following procedure
Number of Participants With AF Recurrence
Number of Participants with AF Recurrence at 6 months and at 12 months after Cryoballoon Ablation for Atrial Fibrillation.
(Chronic Treatment Success is defined as a subject who does not have episodes of AF, lasting at least 30 seconds in duration, 3 months following the initial ablation procedure.)
Measured: 6 months and 12 months
Left Atrial Measurements
Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF
Parameters of atrial function:
1. Volumes at P-wave onset and end-systole
2. LA active emptying volume
3. LA active emptying fraction
4. Late diastolic peak velocity
5. LA filling fraction
6. Pulmonary venous inflow pattern
Measured: Baseline and 6 months
LVEF
Ventricular Function measured by Left Ventricular Ejection Function (LVEF). A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%. An LVEF of 65%, for example means that 65% of total amount of blood in the left ventricle is pumped out with each heartbeat.
Measured: Baseline and 6 months
Left Atrial Volume
Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF
Measured: Baseline and 6 months
Deflections of the Mitral Annulus Measurement
Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF Deflections of the mitral annulus as measured by peak early ventricular diastolic velocity (E'), and during atrial contraction (A')
Measured: Baseline and 6 months

Secondary outcomes (2)

Chronic Treatment Success for the Follow-up Visit Within Treatment Windows.
Chronic Treatment Success for the follow-up visit within treatment windows. 1. Whether on or off Atrial Fibrillation Drugs (AFDs) during the Non-blanked Follow-up Period 2. When off Atrial Fibrillation Drugs
Measured: 3 months
Atrial Flutter
1. Flutter Acute Procedural Success 2. Freedom from Flutter Chronic Treatment Failure
Measured: 3 months

Timeline

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

Jun 2010Jun 2012

First posted12 Jan 2009 (estimated)
Study startJun 2010
Primary completionDec 2011
Study completionJun 2012

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.
Publications (9)Papers the sponsor has linked to this study.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00821015
Sponsor's protocol ID: GCO 09-0628
Acronym: CRYO-LA
Status last verified: Jun 2019
First submitted: 9 Jan 2009
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
Individual data sharing: No

Publications

Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Aug 15;114(7):e257-354. doi: 10.1161/CIRCULATIONAHA.106.177292. No abstract available.
PubMed 16908781
European Heart Rhythm Association (EHRA); European Cardiac Arrhythmia Scoiety (ECAS); American College of Cardiology (ACC); American Heart Association (AHA); Society of Thoracic Surgeons (STS); Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ. HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2007 Jun;4(6):816-61. doi: 10.1016/j.hrthm.2007.04.005. Epub 2007 Apr 30. No abstract available.
PubMed 17556213
Reddy VY, Neuzil P, d'Avila A, Laragy M, Malchano ZJ, Kralovec S, Kim SJ, Ruskin JN. Balloon catheter ablation to treat paroxysmal atrial fibrillation: what is the level of pulmonary venous isolation? Heart Rhythm. 2008 Mar;5(3):353-60. doi: 10.1016/j.hrthm.2007.11.006. Epub 2007 Nov 7.
PubMed 18313591
Van Belle Y, Janse P, Rivero-Ayerza MJ, Thornton AS, Jessurun ER, Theuns D, Jordaens L. Pulmonary vein isolation using an occluding cryoballoon for circumferential ablation: feasibility, complications, and short-term outcome. Eur Heart J. 2007 Sep;28(18):2231-7. doi: 10.1093/eurheartj/ehm227. Epub 2007 Jun 14.
PubMed 17569680
Tsao HM, Wu MH, Huang BH, Lee SH, Lee KT, Tai CT, Lin YK, Hsieh MH, Kuo JY, Lei MH, Chen SA. Morphologic remodeling of pulmonary veins and left atrium after catheter ablation of atrial fibrillation: insight from long-term follow-up of three-dimensional magnetic resonance imaging. J Cardiovasc Electrophysiol. 2005 Jan;16(1):7-12. doi: 10.1046/j.1540-8167.2005.04407.x.
PubMed 15673379
Lemola K, Desjardins B, Sneider M, Case I, Chugh A, Good E, Han J, Tamirisa K, Tsemo A, Reich S, Tschopp D, Igic P, Elmouchi D, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effect of left atrial circumferential ablation for atrial fibrillation on left atrial transport function. Heart Rhythm. 2005 Sep;2(9):923-8. doi: 10.1016/j.hrthm.2005.06.026.
PubMed 16171744
Verma A, Kilicaslan F, Adams JR, Hao S, Beheiry S, Minor S, Ozduran V, Claude Elayi S, Martin DO, Schweikert RA, Saliba W, Thomas JD, Garcia M, Klein A, Natale A. Extensive ablation during pulmonary vein antrum isolation has no adverse impact on left atrial function: an echocardiography and cine computed tomography analysis. J Cardiovasc Electrophysiol. 2006 Jul;17(7):741-6. doi: 10.1111/j.1540-8167.2006.00488.x.
PubMed 16836670
Reant P, Lafitte S, Jais P, Serri K, Weerasooriya R, Hocini M, Pillois X, Clementy J, Haissaguerre M, Roudaut R. Reverse remodeling of the left cardiac chambers after catheter ablation after 1 year in a series of patients with isolated atrial fibrillation. Circulation. 2005 Nov 8;112(19):2896-903. doi: 10.1161/CIRCULATIONAHA.104.523928. Epub 2005 Oct 31.
PubMed 16260634
Yamanaka K, Fujita M, Doi K, Tsuneyoshi H, Yamazato A, Ueno K, Zen E, Komeda M. Multislice computed tomography accurately quantifies left atrial size and function after the MAZE procedure. Circulation. 2006 Jul 4;114(1 Suppl):I5-9. doi: 10.1161/CIRCULATIONAHA.105.000968.
PubMed 16820627

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?

Official record

Active, not recruiting
ARIADNE Clinical Trial
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Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingPhase 4
A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Not yet recruiting
Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Balloon Cryoablation on Left Atrial Function (CRYO-LA)
ClinicalTrials.gov ID: NCT00821015
Acronym / sponsor ID: CRYO-LA / GCO 09-0628
Conditions: Atrial Fibrillation
Keywords: cryoablation, recurring arrhythmia, stroke, RF ablation, LA ablation, nodal ablation, catheter ablation
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Vivek ReddyUniversity, hospital or other
Study start: Jun 2010
Primary completion: Dec 2011 (actual)
Study completion: Jun 2012 (actual)
First posted: 12 Jan 2009 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

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

Detailed description

All study subjects will undergo cryoablation.

Study design

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

Arm	Type	Receives
Experimental	Experimental	Device: Pulmonary vein isolation with cryoballoon catheterAll study subjects will undergo cryoablation. This is a non-randomized trial.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Documented paroxysmal atrial fibrillation
≥ 18 and ≤ 85 years of age
Failure of one or more AF Drugs (AFDs).
Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
Ability to understand the requirements of the study

Key exclusion criteria (8 listed)

Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
More than 4 cardioversions in the prior year.
Patients with recent myocardial infarction (less than 2 months) or unstable angina.
Patients with congestive heart failure (NYHA class III or IV).
Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.

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
Pulmonary vein isolation with cryoballoon catheterFor each patient, the balloon catheter will be advanced to the ostium of each pulmonary vein. Once location has been optimized, the balloon will be inflated, and cryoenergy delivery will be initiated. Because the entire surface of the balloon acts as an ablative surface, circumferential ablation of each pulmonary vein will be achieved concurrently. This will be completed for each pulmonary vein for each patient.	Device	Experimental

Primary outcome

Number of Participants With Acute Procedural Success (APS)
Time frame: Immediately following procedure
Acute Procedural Success (APS) is the demonstration of electrical isolation of all 4 PVs or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
Number of Participants With AF Recurrence
Time frame: 6 months and 12 months
Number of Participants with AF Recurrence at 6 months and at 12 months after Cryoballoon Ablation for Atrial Fibrillation. (Chronic Treatment Success is defined as a subject who does not have episodes of AF, lasting at least 30 seconds in duration, 3 months following the initial ablation procedure.)
Left Atrial Measurements
Time frame: Baseline and 6 months
Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF Parameters of atrial function: 1. Volumes at P-wave onset and end-systole 2. LA active emptying volume 3. LA active emptying fraction 4. Late diastolic peak velocity 5. LA filling fraction 6. Pulmonary venous inflow pattern
LVEF
Time frame: Baseline and 6 months
Ventricular Function measured by Left Ventricular Ejection Function (LVEF). A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%. An LVEF of 65%, for example means that 65% of total amount of blood in the left ventricle is pumped out with each heartbeat.
Left Atrial Volume
Time frame: Baseline and 6 months
Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF
Deflections of the Mitral Annulus Measurement
Time frame: Baseline and 6 months
Transthoracic Echo Assessment of Left Atrial Function at Baseline and 6-Months Post- Cryoballoon Ablation for AF Deflections of the mitral annulus as measured by peak early ventricular diastolic velocity (E'), and during atrial contraction (A')

2 secondary outcomes

Chronic Treatment Success for the Follow-up Visit Within Treatment Windows.
Time frame: 3 months
Atrial Flutter
Time frame: 3 months

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cryoballoon Catheter	27	15

Primary outcome: Number of Participants With Acute Procedural Success (APS)

Time frame: Immediately following procedure. Count of participants. Unit: Participants

Measure	Cryoballoon Catheter n = 27
Value	27

Primary outcome: Number of Participants With AF Recurrence

Time frame: 6 months and 12 months. Count of participants. Unit: Participants

Measure	Cryoballoon Catheter n = 26
6 months	3
12 months	1

Population analysed: Only subjects who returned for their visit was included in analysis

Primary outcome: Left Atrial Measurements

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: cm

Measure	Cryoballoon Catheter n = 18
Parasternal baseline	3.79 (0.55)
Parasternal 6 months	3.77 (0.54)
Longitudinal baseline	5.70 (0.72)
Longitudinal 6 months	5.33 (0.9)
Transverse baseline	4.21 (0.61)
Transverse 6 months	3.82 (0.95)

Population analysed: Echocardiogram data was incomplete for 9 patients.

Primary outcome: LVEF

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: percentage of blood

Measure	Cryoballoon Catheter n = 18
Baseline	59 (0.05)
6 months	62 (0.09)

Population analysed: Echocardiogram data was incomplete for 9 patients.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cryoballoon Catheter	1 of 27 (3.7%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16908781Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Aug 15;114(7):e257-354. doi: 10.1161/CIRCULATIONAHA.106.177292. No abstract available.
Background: PubMed 17556213European Heart Rhythm Association (EHRA); European Cardiac Arrhythmia Scoiety (ECAS); American College of Cardiology (ACC); American Heart Association (AHA); Society of Thoracic Surgeons (STS); Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ. HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2007 Jun;4(6):816-61. doi: 10.1016/j.hrthm.2007.04.005. Epub 2007 Apr 30. No abstract available.
Background: PubMed 18313591Reddy VY, Neuzil P, d'Avila A, Laragy M, Malchano ZJ, Kralovec S, Kim SJ, Ruskin JN. Balloon catheter ablation to treat paroxysmal atrial fibrillation: what is the level of pulmonary venous isolation? Heart Rhythm. 2008 Mar;5(3):353-60. doi: 10.1016/j.hrthm.2007.11.006. Epub 2007 Nov 7.
Background: PubMed 17569680Van Belle Y, Janse P, Rivero-Ayerza MJ, Thornton AS, Jessurun ER, Theuns D, Jordaens L. Pulmonary vein isolation using an occluding cryoballoon for circumferential ablation: feasibility, complications, and short-term outcome. Eur Heart J. 2007 Sep;28(18):2231-7. doi: 10.1093/eurheartj/ehm227. Epub 2007 Jun 14.
Background: PubMed 15673379Tsao HM, Wu MH, Huang BH, Lee SH, Lee KT, Tai CT, Lin YK, Hsieh MH, Kuo JY, Lei MH, Chen SA. Morphologic remodeling of pulmonary veins and left atrium after catheter ablation of atrial fibrillation: insight from long-term follow-up of three-dimensional magnetic resonance imaging. J Cardiovasc Electrophysiol. 2005 Jan;16(1):7-12. doi: 10.1046/j.1540-8167.2005.04407.x.
Background: PubMed 16171744Lemola K, Desjardins B, Sneider M, Case I, Chugh A, Good E, Han J, Tamirisa K, Tsemo A, Reich S, Tschopp D, Igic P, Elmouchi D, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effect of left atrial circumferential ablation for atrial fibrillation on left atrial transport function. Heart Rhythm. 2005 Sep;2(9):923-8. doi: 10.1016/j.hrthm.2005.06.026.
Background: PubMed 16836670Verma A, Kilicaslan F, Adams JR, Hao S, Beheiry S, Minor S, Ozduran V, Claude Elayi S, Martin DO, Schweikert RA, Saliba W, Thomas JD, Garcia M, Klein A, Natale A. Extensive ablation during pulmonary vein antrum isolation has no adverse impact on left atrial function: an echocardiography and cine computed tomography analysis. J Cardiovasc Electrophysiol. 2006 Jul;17(7):741-6. doi: 10.1111/j.1540-8167.2006.00488.x.
Background: PubMed 16260634Reant P, Lafitte S, Jais P, Serri K, Weerasooriya R, Hocini M, Pillois X, Clementy J, Haissaguerre M, Roudaut R. Reverse remodeling of the left cardiac chambers after catheter ablation after 1 year in a series of patients with isolated atrial fibrillation. Circulation. 2005 Nov 8;112(19):2896-903. doi: 10.1161/CIRCULATIONAHA.104.523928. Epub 2005 Oct 31.
Background: PubMed 16820627Yamanaka K, Fujita M, Doi K, Tsuneyoshi H, Yamazato A, Ueno K, Zen E, Komeda M. Multislice computed tomography accurately quantifies left atrial size and function after the MAZE procedure. Circulation. 2006 Jul 4;114(1 Suppl):I5-9. doi: 10.1161/CIRCULATIONAHA.105.000968.
Individual participant dataSharing planned: No

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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.

Vivek Y Reddy, MD principal investigator

Icahn School of Medicine at Mount Sinai

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary vein isolation with cryoballoon catheter in people with Atrial Fibrillation, run by Vivek Reddy.

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 6 inclusion and 8 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

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 5 Jul 2019). 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?

Number of Participants With Acute Procedural Success (APS) (time frame: Immediately following procedure). The study lists 6 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 NCT00821015, which also lists 9 linked publications.

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 5 Jul 2019.