Permanent Atrial Fibrillation
Conditions
Keywords
Permanent atrial fibrillation, VVI(R) pacing, rate regularization
Brief summary
The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).
Detailed description
The RARE PEARL is a multicenter prospective, randomized, double-blinded, crossover study. Prior entering the study the patient should be informed and should give his written consent. Besides he/she should meet all selection criteria. The Investigator has to check that all selection criteria are satisfied. Then the patient undergoes pacemaker implantation, receiving a pacemaker model C20 SSIR or T20 SSIR (or later). The ventricular lead must be bipolar independently of the manufacturer. After pacemaker implantation, a 45 days Stabilization Period is necessary to stabilize leads and drug therapy. At the end of the stabilization period the patient is randomized to have VRS algorithm switched either ON or OFF. The 1° Study Phase ends after 2 months. Then a cross-over takes place: VRS algorithm is switched respectively OFF or ON and the 2° Study Phase is started. Also the 2° Study Phase ends after 2 months. The randomization will be centralized: randomization lists will be generated and managed by the sponsor. Because the patients will undergo a QoL questionnaire at each crossover phase, they will have to be blinded about the status of their VRS setting. Similarly, also the co-investigators administering the QoL questionnaires have to be blinded about the status of VRS setting. Only the principal investigator knows if the VRS algorithm is ON or OFF. The principal investigator will be instructed not to inform the patient and the co-investigators administering QoL questionnaire about the setting until after the end of the study. The co-investigator(s) responsible for QoL questionnaire should not perform the patient follow-up at 1° and 2° Study Phase, otherwise the patient is automatically excluded from the study. After the cross-over period (2 + 2 months) a Free Therapy Phase (3° Phase) starts. Device settings and drug therapy are left to the physician's discretion. One year after implantation a final follow-up is scheduled. The study ends and the pacemaker can be programmed according to the physician's discretion.
Interventions
DEVICEVitatron pacemaker C20 SSIR or T20 SSIR models
VRS: special function that automatically adapts pacing rate to regularize cardiac cycles
Sponsors
Medtronic
Medtronic BRC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has signed informed consent form * Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and at least 1 episode of rate irregularity in the last month * New York Heart Association (NYHA) Class I, II, III * Patient is able to comply with follow-up times and will comply with the protocol * \> 18 years of age
Exclusion criteria
* Paroxysmal atrial fibrillation * NYHA Class IV * Left ventricular ejection fraction (LVEF) \< 35 * Patients with unstable angina * Patients who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior to enrolment * Patient candidate for cardiac surgery, or coronary angioplasty (PTCA) * Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack (TIA) with permanent disability * Life expectancy \< 12 months due to other medical conditions * Pregnancy * The patient is enrolled in any concurrent (drug and/or device) study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) | June 2009 | Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Rate Irregularity Indicators and Patient's Symptoms | January 2009 |
| Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation | January 2009 |
| Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate | January 2009 |
| Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization | January 2009 |
Countries
Italy
Participant flow
Recruitment details
enrollment period: from january 2006 till november 2008
Participants by arm
| Arm | Count |
|---|---|
| VRS ON Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON) | 34 |
| VRS OFF Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON) | 33 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1 | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | VRS OFF | VRS ON | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 34 Participants | 67 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 80 years STANDARD_DEVIATION 6 | 80 years STANDARD_DEVIATION 6 | 80 years STANDARD_DEVIATION 6 |
| Region of Enrollment Italy | 33 participants | 34 participants | 67 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 24 Participants | 25 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 2 / 34 | 0 / 33 |
Outcome results
Primary
Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)
Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.
Time frame: June 2009
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VRS ON | Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) | Preference VRS ON | 32 participants |
| VRS ON | Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) | Preference VRS OFF | 15 participants |
| VRS ON | Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) | No Preference | 19 participants |
| VRS OFF | Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) | Preference VRS ON | 32 participants |
| VRS OFF | Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) | Preference VRS OFF | 15 participants |
| VRS OFF | Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) | No Preference | 19 participants |
Comparison: VRS ON vs. VRS OFFp-value: <0.000195% CI: [36, 61]Z-test for proportions
Secondary
Evaluation of Rate Irregularity Indicators and Patient's Symptoms
Time frame: January 2009
Secondary
Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation
Time frame: January 2009
Secondary
Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate
Time frame: January 2009
Secondary
Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization
Time frame: January 2009