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New treatment option for Reflex Syncope
Official title Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
ClinicalTrials.gov ID: NCT05855603
What this study is testing
- What it's testing
- Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Aged more than 40 years.
- Having a 12-month history that includes at least two documented episodes of spontaneous reflex syncope or one episode that led to injury in addition...
- Bradycardia-syncope correlation (at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block) confirmed by ECG during spontaneous...
- If lacking ECG evidence during spontaneous syncope, a cardioinhibitory response (VASIS type 2A or 2B) on tilt test.
- Displaying indicators for pacing such as those suggested in the ESC guidelines for a class I recommendation for patients with reflex syncope.
You likely can't join if
- Intrinsic sinus or atrioventricular nodal disease with a proven indication for permanent pacemaker implantation.
- Evidence of structural heart disease.
- Contraindications to ablation in the right or left atrium.
- Life expectancy \<12 months.
- Lacking willingness to comply with the randomization procedure.
See the full eligibility criteria
- Aged more than 40 years.
- Having a 12-month history that includes at least two documented episodes of spontaneous reflex syncope or one episode that led to injury in addition to at least two presyncopal events, refractory to all recommended...
- Bradycardia-syncope correlation (at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block) confirmed by ECG during spontaneous syncope.
- If lacking ECG evidence during spontaneous syncope, a cardioinhibitory response (VASIS type 2A or 2B) on tilt test.
- Displaying indicators for pacing such as those suggested in the ESC guidelines for a class I recommendation for patients with reflex syncope.
- Significantly decreased quality of life due to syncope.
- Sinus rhythm on ECGs.
- Obtained written informed consent.
- Intrinsic sinus or atrioventricular nodal disease with a proven indication for permanent pacemaker implantation.
- Evidence of structural heart disease.
- Contraindications to ablation in the right or left atrium.
- Life expectancy \<12 months.
- Lacking willingness to comply with the randomization procedure.
The study team makes the final eligibility decision.
Where it's taking place
- Sant Joan d'Alacant, Alicante, Spain
- Castellon, Castellón, Spain
- Vigo, Pontevedra, Spain
- Barcelona, Spain
- Girona, Spain
- Santa Cruz de Tenerife, Spain
- Valencia, Spain
- Zaragoza, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sant Joan d'Alacant, Alicante, Spain; Castellon, Castellón, Spain; Vigo, Pontevedra, Spain; Barcelona, Spain; Girona, Spain; Santa Cruz de Tenerife, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.