Trial Outcomes & Findings for Investigation of Therapeutic Ablation Versus Cardioversion for AF (NCT NCT03907982)
NCT ID: NCT03907982
Last Updated: 2025-06-26
Results Overview
Data on epsiodes of Atrial Fibrillation (rate, duration) will be provided by the loop recorder, and downloaded via a home monitoring system
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Within 12 months following the procedure
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
DCCV + PVI
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of Therapeutic Ablation Versus Cardioversion for AF
Baseline characteristics by cohort
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 6 • n=5 Participants
|
72 years
STANDARD_DEVIATION 7 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 12 months following the procedureData on epsiodes of Atrial Fibrillation (rate, duration) will be provided by the loop recorder, and downloaded via a home monitoring system
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Recurrence of Persistent AF (of AF Episode Lasting > 7 Days).
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 12 months of study recruitmentDeath of the patient
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 12 months following the procedureRates of admission of the subject back to hospital following the initial treatment for AF
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Rates of Subject Hospital Re-admission
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At the time of the procedureAssessment of rates of events that are considered procedural complications during the DCCV +/- Pulmonary Vein isolation (PVI) procedure
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Procedural Complications
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of the procedureRates of bleeding in subjects following the study DCCV +/- pulmonary vein isolation (PVI) procedures
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Bleeding Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 12 months following the procedureRequirement for repeat procedures following the initial DCCV +/- pulmonary vein isolation (PVI) procedure for the study
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Rates of Repeat Procedures
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Within 12 months following the procedureClinical procedural success as defined by 75% or greater reduction in the number of AF episodes as measured by the insertable cardiac monitoring system (LINQ) device.
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Clinical Success of Procedure
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Between baseline and 12 months after procedurePopulation: A "low scale" indicates poorer health-related quality of life with Higher scores indicate a better outcome.
Assessment of quality of life measures using Short Form Health Survey (SF12) questionnaire, which is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions are combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Scale range from 0 to 100, with higher scores indicating better quality of life.
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Change in Quality of Life Measures (Using Short Form-12 Survey)
|
12.21 units on a scale
Standard Deviation 11.37
|
14.15 units on a scale
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: between baseline and 12 months after procedurePopulation: A "low scale" indicates poorer health-related quality of life with higher scores indicate a better outcome.
Assessment of Patient Reported Outcome Measures (PROMS) specific for Atrial Fibrillation (AF) in a series of 28 questions to assess the impact of AF on the subject's quality of life. Atrial Fibrillation Severity Scale (AFSS) uses a scale ranging from 0 to 35, where a higher score indicates more severe symptoms.
Outcome measures
| Measure |
DCCV + PVI
n=10 Participants
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 Participants
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Change in Quality of Life Measures (AF-PROMS)
|
-23 units on a scale
Standard Deviation 22
|
-2 units on a scale
Standard Deviation 10
|
Adverse Events
DCCV + PVI
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DC Cardioversion (DCCV) + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DCCV + PVI
n=10 participants at risk
DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation)
At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Pulmonary vein isolation: The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
DC Cardioversion (DCCV) + Placebo
n=10 participants at risk
Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.
DC Cardioversion: DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
Implantable loop recorder: The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
incisionla site bleeding
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/10 • 12 months
|
Additional Information
Dr Malcolm Finlay, Principal Investigator
Barts and London NHS trust
Phone: +442037658635
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place