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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation. (PAF)
This trial was a non-randomized, multi-center, prospective study of subjects with symptomatic, paroxysmal atrial fibrillation (PAF). The purpose of this study was to investigate and confirm the safety, efficacy and efficiency of the Medtronic Ablation Frontiers® Cardiac Ablation System when used for the treatment of paroxysmal AF. The trial was conducted over a 2 year period with enrollment occurring between 4 October 2007 and 1 December 2008.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablated Patients | Experimental | Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF Ablation procedure | Procedure | Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Pulmonary Vein Isolation | Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter. | 6 months |
| Chronic Effectiveness | The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months. | 6 months |
| Acute Safety | The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site. | 7 days post procedure |
| Chronic Safety | The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site. | 7 day post procedure to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic). |
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Inclusion Criteria:
History of symptomatic paroxysmal atrial fibrillation defined as:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark | ||||
| Hjertecenter Varde |
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| Label | URL |
|---|---|
| Company website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ablated Participants | Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ablated Participants | Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Successful Pulmonary Vein Isolation | Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter. | Subjects that had successful pulmonary vein isolation. | Posted | Number | participants | 6 months |
|
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All adverse events were collected up to 6 months.
The seriousness and relatedness of all AEs were assessed by the investigator at each site. The AE's included: Cerobrovascular accident, Major bleeding, Cardiac tamponade, Pulmonary vein stenosis, Pericarditis, Myocardial infarction, Diaphragmatic paralysis, Atrio-esophageal fistula, and Death.
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ablated Participants | Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | General disorders | Systematic Assessment | Back pain as a result of a car accident |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Nelson, RN, BSN, MBA- AF Solutions Clinical Operations Director | Medtronic AF Solutions | (763)526-2891 | linda.k.nelson@medtronic.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
| 6 Months |
| The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score. | 6 months |
| Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins | Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation | After Procedure |
| Total Procedure Time | Measurement of total procedure time defined as "skin to skin" and left atrial dwell time (transseptal puncture to removal of all left atrial catheters) | End of Procedure |
| Total Fluoroscopy Time | Total time that flouroscopy was used during the ablation procedure. | Post Ablation Procedure |
| Varde |
| Denmark |
| Zentralklinik | Bad Berka | Germany |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Klinik im Park | Zurich | Switzerland |
| Unable to accomodate schedule |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Chronic Effectiveness | The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months. | The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. | Posted | Number | participants | 6 months |
|
|
|
| Primary | Acute Safety | The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site. | The proportion of subjects with one or more serious procedure and/or device related AEs occurring within 7 days of the ablation procedure. No acute events were related to the device. | Posted | Number | participants | 7 days post procedure |
|
|
|
| Primary | Chronic Safety | The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site. | The Chronic Safety Endpoint is the proportion of subjects with serious procedure and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site. | Posted | Number | participants | 7 day post procedure to 6 months |
|
|
|
| Secondary | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic). | Posted | Mean | Standard Deviation | units on a scale | 6 Months |
|
|
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| Secondary | The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins | Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation | Posted | Mean | Standard Deviation | minutes | After Procedure |
|
|
|
| Secondary | Total Procedure Time | Measurement of total procedure time defined as "skin to skin" and left atrial dwell time (transseptal puncture to removal of all left atrial catheters) | Posted | Mean | Standard Deviation | minutes | End of Procedure |
|
|
|
| Secondary | Total Fluoroscopy Time | Total time that flouroscopy was used during the ablation procedure. | Posted | Mean | Standard Deviation | minutes | Post Ablation Procedure |
|
|
|
| 9 |
| 55 |
| 19 |
| 55 |
| Chest Discomfort | Surgical and medical procedures | Systematic Assessment |
|
| Collapse After AF recurrence | Cardiac disorders | Systematic Assessment |
|
| Arrythmia, pro arrhythmia | Cardiac disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Sudden Deafness followed by tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Heart Catheterization | Surgical and medical procedures | Systematic Assessment |
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| Cerebrovascular Accident- Ischemic attack | Vascular disorders | Systematic Assessment |
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| Arrythmia, proarrythmia | Cardiac disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment | Headache as a result of a car accident. |
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| Allergic reaction | Immune system disorders | Systematic Assessment | Allergic reaction to contrast media. |
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| Dizziness | General disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Cerebrovascular Accident/ Ischemic Attack | Vascular disorders | Systematic Assessment |
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| Infections | Infections and infestations | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| Shortness of Breath |
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| Lightheadedness / Dizziness |
|
| Lack of Energy During Exertion or Exercise |
|
| Total AF Symptom Severity Score |
|
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