Paroxysmal Atrial Fibrillation
Conditions
Keywords
atrial fibrillation
Brief summary
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)
Detailed description
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.
Interventions
PROCEDURERF Ablation 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.
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
History of symptomatic paroxysmal atrial fibrillation defined as: * Self terminating AF lasting no more than 7 days * AF events demostrating spontaneous conversion back to sinus rhythm * Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year * AF symptoms defined as the manisfestation of any of the following: Palpitations, Fatigue, Exertional dyspnea, effort intolerance * Age between 18 and 70 * Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Exclusion criteria
* Structural heart disease of clinical significance * Prior ablation for arrhythmias other than AF within the past three months * Prior left sided AF ablation * Enrollment in any other ongoing arrhythmia study protocol * Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study * Active infection or sepsis * Any history of cerebral vascular disease including stroke or TIAs * Pregnancy or lactation * Untreatable allergy to contrast media * Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes * History of blood clotting (bleeding or thrombotic) abnormalities * Known sensitivities to heparin or warfarin * Severe COPD (identified by an FEV1 \< 1) * Severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Pulmonary Vein Isolation | 6 months | 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. |
| Chronic Effectiveness | 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. 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. |
| Acute Safety | 7 days post procedure | 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. |
| Chronic Safety | 7 day post procedure to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | 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). |
| Total Fluoroscopy Time | Post Ablation Procedure | Total time that flouroscopy was used during the ablation procedure. |
| The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | 6 months | 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. |
| Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins | After Procedure | Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation |
| Total Procedure Time | End of Procedure | Measurement of total procedure time defined as skin to skin and left atrial dwell time (transseptal puncture to removal of all left atrial catheters) |
Countries
Denmark, Germany, Netherlands, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Study Device not available at procedure | 1 |
| Overall Study | Unable to accomodate schedule | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ablated Participants |
|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment Denmark | 18 participants |
| Region of Enrollment Germany | 7 participants |
| Region of Enrollment Netherlands | 21 participants |
| Region of Enrollment Switzerland | 9 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 55 |
| serious Total, serious adverse events | 9 / 55 |
Outcome results
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.
Time frame: 7 days post procedure
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablated Participants | Acute Safety | 2 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.
Time frame: 6 months
Population: The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablated Participants | Chronic Effectiveness | 10 participants |
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.
Time frame: 7 day post procedure to 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablated Participants | Chronic Safety | 0 participants |
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.
Time frame: 6 months
Population: Subjects that had successful pulmonary vein isolation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablated Participants | Number of Participants With Successful Pulmonary Vein Isolation | 53 participants |
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).
Time frame: 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablated Participants | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Fatigue | 3.2 units on a scale | Standard Deviation 1.1 |
| Ablated Participants | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Shortness of Breath | 2.7 units on a scale | Standard Deviation 1.2 |
| Ablated Participants | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Total AF Symptom Severity Score | 15.4 units on a scale | Standard Deviation 4.1 |
| Ablated Participants | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Palpitations | 3.4 units on a scale | Standard Deviation 1 |
| Ablated Participants | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Lightheadedness / Dizziness | 2.7 units on a scale | Standard Deviation 1.2 |
| Ablated Participants | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Lack of Energy During Exertion or Exercise | 3.3 units on a scale | Standard Deviation 0.9 |
| Ablated Patients Symptom Severity Score at 3 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Lightheadedness / Dizziness | 1.5 units on a scale | Standard Deviation 0.9 |
| Ablated Patients Symptom Severity Score at 3 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Lack of Energy During Exertion or Exercise | 2.1 units on a scale | Standard Deviation 1.1 |
| Ablated Patients Symptom Severity Score at 3 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Total AF Symptom Severity Score | 9.4 units on a scale | Standard Deviation 4.4 |
| Ablated Patients Symptom Severity Score at 3 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Fatigue | 2 units on a scale | Standard Deviation 1.2 |
| Ablated Patients Symptom Severity Score at 3 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Palpitations | 1.9 units on a scale | Standard Deviation 1 |
| Ablated Patients Symptom Severity Score at 3 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Shortness of Breath | 1.9 units on a scale | Standard Deviation 1.1 |
| Ablated Patients Symptom Severity Score at 6 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Total AF Symptom Severity Score | 9.2 units on a scale | Standard Deviation 4.7 |
| Ablated Patients Symptom Severity Score at 6 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Palpitations | 1.9 units on a scale | Standard Deviation 1 |
| Ablated Patients Symptom Severity Score at 6 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Fatigue | 1.9 units on a scale | Standard Deviation 1.1 |
| Ablated Patients Symptom Severity Score at 6 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Shortness of Breath | 1.8 units on a scale | Standard Deviation 1.1 |
| Ablated Patients Symptom Severity Score at 6 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Lack of Energy During Exertion or Exercise | 2.1 units on a scale | Standard Deviation 1.3 |
| Ablated Patients Symptom Severity Score at 6 Months | Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months | Lightheadedness / Dizziness | 1.5 units on a scale | Standard Deviation 1 |
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
Time frame: After Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ablated Participants | Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins | 56.3 minutes | Standard Deviation 37.1 |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablated Participants | The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | Physical Component Score | 46.4 units on a scale | Standard Deviation 9.7 |
| Ablated Participants | The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | Mental Compnent Score | 46.8 units on a scale | Standard Deviation 11.7 |
| Ablated Patients Symptom Severity Score at 3 Months | The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | Physical Component Score | 50.4 units on a scale | Standard Deviation 9.2 |
| Ablated Patients Symptom Severity Score at 3 Months | The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | Mental Compnent Score | 49.4 units on a scale | Standard Deviation 10 |
| Ablated Patients Symptom Severity Score at 6 Months | The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | Physical Component Score | 51.8 units on a scale | Standard Deviation 8.1 |
| Ablated Patients Symptom Severity Score at 6 Months | The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline | Mental Compnent Score | 51.6 units on a scale | Standard Deviation 9 |
Secondary
Total Fluoroscopy Time
Total time that flouroscopy was used during the ablation procedure.
Time frame: Post Ablation Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ablated Participants | Total Fluoroscopy Time | 26 minutes | Standard Deviation 15.4 |
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)
Time frame: End of Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ablated Participants | Total Procedure Time | 117.9 minutes | Standard Deviation 58.2 |