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Prematurely closed due to ongoing challenging enrollment requirements.
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Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF.
Introduction: Among the cardiac arrhythmias, Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population and represents an increasing problem worldwide. Management strategies for AF include combinations of various treatments, including surgery. Cox et al. developed the surgical Maze procedure to restore sinus conduction to the AV node and to restore effective, synchronized bi-atrial contraction. In an effort to address the observed challenges and make this treatment available to more subjects, modifications of the Maze pattern and new lesion patterns have being developed and tested. Devices using new technologies, like cryothermia, were developed in an effort to reduce the time required to make the lesion pattern.The Cardioblate® CryoFlex™ Surgical Ablation System has been successfully used for the surgical ablation of cardiac arrhythmias including atrial fibrillation. The system utilizes cryothermia to create the linear lesions of the surgical Maze-III procedure.
Purpose: To provide clinical evidence showing that the Cox Cryo Maze III procedure is effective and safe in subjects with longstanding persistent AF undergoing mitral valve repair or replacement.
Study objective: The study objectives were to characterize the safety and efficacy of the Medtronic Cardioblate CryoFlex Surgical Ablation System when used to treat subjects with longstanding persistent AF requiring concomitant mitral valve repair or replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Experimental | Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery. During surgery, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor future episodes of AF. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioblate CryoFlex Surgical Ablation | Device | Longstanding persistent AF was treated with the Cox Cryo Maze III procedure During mitral valve surgery a surgical ablation was performed, using the Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation. | The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden < 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period. | 12 months |
| Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | The composite MAE was defined as a subject experiencing any of the following adverse events:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | 12 Months | |
| Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Vang, MD | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Leipzig GmbH | Leipzig | Germany | ||||
| Sheba Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardioblate CryoFlex Surgical Ablation | Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Mitral Valve surgery | Procedure | Classic mitral valve surgery was performed |
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| Medtronic Reveal XT Insertable Cardiac Monitor | Device | During the procedure, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor episodes of AF during follow-up period |
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| MAZE III | Procedure | Longstanding persistent AF was treated with the Cox Cryo Maze III procedure |
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| Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | 6 Months |
| AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months | AF burden is defined as percentage of time the patient is in AF during 24 hours. | 3, 6 and 12 Months |
| Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | The 12-Item Short Form Health Survey (SF-12) is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Ten summary scores are reported from the SF-12. The scale range for each of the ten subscales is from 0 to 100, with higher scores corresponding to a better outcome. Subjects average unit score (with standard deviation) are reported at baseline, 6 and 12 months. As unit of measure we used units on a scale. | 6 and 12 months |
| Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | The composite MAE was defined as a subject experiencing any of the following adverse events:
| 12 months |
| Tel Litwinsky |
| Israel |
| San Raffaele Hospital | Milan | 20149 | Italy |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Treated |
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| Discharge /1 Month Post-procedure |
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| 3 Months Post-procedure |
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| 6 Months Post-procedure |
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| COMPLETED | 12 months post-procedure |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardioblate CryoFlex Surgical Ablation | Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| NYHA Class | NYHA I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea. NYHA II: slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation. | The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden < 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period. | There were 11 subjects with data at 12 months, including antiarrhythmic drug, ablation, and cardioversion data. However, only six subjects had the AF burden data required for the primary efficacy endpoint. | Posted | Count of Participants | Participants | 12 months |
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| Primary | Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last | The composite MAE was defined as a subject experiencing any of the following adverse events:
| All subjects treated with the Cardioblate Cryoflex Surgical Ablation System. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | All subjects who underwent ablation therapy and who had data from the Reveal XT Insertable Cardiac Monitor | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months | AF burden is defined as percentage of time the patient is in AF during 24 hours. | Posted | Mean | Standard Deviation | percentage of AF burden | 3, 6 and 12 Months |
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| Secondary | Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure | The 12-Item Short Form Health Survey (SF-12) is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Ten summary scores are reported from the SF-12. The scale range for each of the ten subscales is from 0 to 100, with higher scores corresponding to a better outcome. Subjects average unit score (with standard deviation) are reported at baseline, 6 and 12 months. As unit of measure we used units on a scale. | Posted | Mean | Standard Deviation | units on a scale | 6 and 12 months |
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| Secondary | Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last | The composite MAE was defined as a subject experiencing any of the following adverse events:
| Posted | Count of Participants | Participants | 12 months |
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12 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Cardioblate CryoFlex Surgical Ablation Group With 12 Months of | Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to Mitral valve surgery Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted. | 1 | 17 | 9 | 17 | 3 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischemic Attack | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Ventriculr Block, Second Degree | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Haemodynamic Instability | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| Retroperitoneal Haematoma | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Clostridium Difficile Colitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Arterial Injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Pulmonary Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Ventricular Dysfunction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Bundle Branch Block, Right | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Haematoma Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Intracardiac Thrombus | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Atrioventricular Block, Complete | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Postoperative Renal Failure | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Systemic Inflammatory Response Syndrome | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Transient Psychosis | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Hyponatriaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Postoperative Delirium | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Postoperative Anemia | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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Study was prematurely stopped due to sustained difficulties in the recruitment of eligible subjects. As a result only 17 subjects were enrolled in the study. Reveal XT data were retrievable in only 6 of the enrolled subjects.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ber Kleijnen, Sr Clinical Research Manager | Medtronic, Bakken Research Center, Coronary and Structural Heart Disease Management (CSH), Endepolsdomein 5, 6229 GW Maastricht, The Netherlands | +31653227763 | ber.kleijnen@medtronic.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000079042 | Maze Procedure |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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| NYHA Class III |
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| NYHA Class IV |
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| AF Burden in Treated Subjects After 12 Months Follow-Up |
Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted. |
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| OG002 | Quality of Life of Treated Subjects at 12 Months Follow-Up | Subjects with longstanding persistent AF undergoing Maze III procedure using the Cardioblate CryoFlex Surgical Ablation System concomittant to mitral valve surgery Maze III procedure with Cardioblate CryoFlex Surgical Ablation System: During planned mitral valve surgery, longstanding persistent AF was treated with the Cox Cryo Maze III procedure by using Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted. |
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